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The Healthcare Sales & Marketing Network celebrates 28 years serving the medical sales & marketing community.Connecting Medical Sales Reps with MedTech/BioPharma Recruiters and Independent Reps with and New Product LinesConnecting Medical Sales Reps with MedTech/BioPharma Recruiters and Independent Reps with and New Product Lines

Searching News Database:  FDA 


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 HSMN NewsFeed - 30 Jul 2026
CereVasc Opens New Massachusetts Facility in Preparation for eShunt(R) System Commercialization
Devices Neurosurgery
 HSMN NewsFeed - 28 Jul 2026
BrainStorm Appoints Former FDA Associate Commissioner Peter J. Pitts as Executive Chairman
Regenerative Medicine Neurology Personnel
 HSMN NewsFeed - 27 Jul 2026
IceCure Medical Kicks Off its Post-Marketing "ChoICE" Study for the Low-Risk Breast Cancer Treatment at First U.S Clinical Site
Devices Oncology
 HSMN NewsFeed - 24 Jul 2026
Roche Receives FDA Clearance for the Cobas(R) BV/CV Assay, Enabling Fast and Highly Accurate Vaginitis Diagnosis
Diagnostics FDA
 HSMN NewsFeed - 20 Jul 2026
Mentari Therapeutics Appoints Industry Veteran Greg Divis as Chief Executive Officer
Biopharmaceuticals Neurology Personnel
 HSMN NewsFeed - 13 Jul 2026
Aethlon Medical Continues to Observe Directional Changes in Second Cohort of Australian Oncology Clinical Trial Evaluating Hemopurifier(R)
Devices Oncology
 HSMN NewsFeed - 9 Jul 2026
Foresee Pharmaceuticals Appoints Brian J. Groch as Chief Commercial Officer to Spearhead Commercial Launch of FP-001 42 mg for Central Precocious Puberty
Biopharmaceuticals Personnel
 HSMN NewsFeed - 8 Jul 2026
Ventris Medical Addresses Unmet Surgical Needs with New Connext Surgical Matrix
Devices Wound Care Product Launch FDA
 HSMN NewsFeed - 6 Jul 2026
IceCure Highlights Expanding Commercial Adoption of ProSense(TM) Cryoablation in Brazil Following FDA Clearance for Breast Cancer
Devices Oncology
 HSMN NewsFeed - 2 Jul 2026
Spinogenix Appoints Professor Joseph T. Coyle, MD, Current Chair of Psychiatry and Neuroscience at Harvard Medical School, to Scientific Advisory Board
Biopharmaceuticals Neurology Personnel
 HSMN NewsFeed - 1 Jul 2026
STARMED Receives FDA 510(k) Clearance for a Benign Thyroid Nodule Ablation Indication
Devices FDA
 HSMN NewsFeed - 29 Jun 2026
Theravance Biopharma Enters into Definite Agreement to be Acquired by Zymeworks for $17.00 Per Share in Cash Plus a Contingent Value Right
Biopharmaceuticals Mergers & Acquisitions
 HSMN NewsFeed - 24 Jun 2026
ADC Therapeutics Announces Strategic Reorganization to Support ZYNLONTA(R) Growth Opportunities and Regulatory Priorities
Biopharmaceuticals Oncology
 HSMN NewsFeed - 23 Jun 2026
CereVasc, Inc. Completes Enrollment in STRIDE Pivotal Trial of the eShunt(R) System
Devices Neurosurgery
 HSMN NewsFeed - 22 Jun 2026
Labcorp Announces Nationwide Availability of ColoSense(R), the First FDA-Approved RNA-Based At-Home Colorectal Cancer Screening Test
Diagnostics Oncology FDA
 HSMN NewsFeed - 18 Jun 2026
Amplio Spine Acquires and Commercializes KeyLift(R), an FDA-Cleared Expandable Interlaminar Stabilization System Indicated for Supplemental Fusion of the Non-Cervical Spine
Devices Orthopaedic Acquisitions Product Launch
 HSMN NewsFeed - 15 Jun 2026
Celltaxis Names Co-Founder Eileen Heffernan as CEO to Accelerate Growth and Expand Leadership in Lymphatic Disease Therapeutics
Biopharmaceuticals Personnel
 HSMN NewsFeed - 11 Jun 2026
Viking Therapeutics Announces Appointment of Hubert C. Chen, M.D., as Chief Medical Officer
Biopharmaceuticals Personnel
 HSMN NewsFeed - 10 Jun 2026
Subtle Medical Receives FDA Clearance for SubtleHD(TM)(CT), Expanding AI-Powered Image Enhancement into CT Imaging
Devices Radiology FDA
 HSMN NewsFeed - 9 Jun 2026
SpinaFX Medical receives FDA Investigational Device Exemption (IDE) for Triojection(R), its Breakthrough, Minimally-Invasive, Image-Guided Lumbar Disc Treatment
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 5 Jun 2026
Neuronoff Implants First Patient in DOD-Funded Trial of Injectrode(R) for Neurogenic Bladder in Spinal Cord Injury
Devices Urology
 HSMN NewsFeed - 4 Jun 2026
CereVasc, Inc. Announces Over-Subscribed $85 Million Series C Financing to Advance its Novel eShunt(R) System for the Treatment of Normal Pressure Hydrocephalus
Devices Interventional Neurosurgery Venture Capital
 HSMN NewsFeed - 29 May 2026
SKIA HEAD: AR Surgical Guidance Receives FDA 510(k) Clearance, Eyes U.S. Expansion with Structure Partnership
Devices Surgery FDA
 HSMN NewsFeed - 28 May 2026
NOWDiagnostics Appoints Lisa Nibauer as Chief Executive Officer to Lead Next Phase of Innovation and Transformation
Diagnostics Personnel
 HSMN NewsFeed - 27 May 2026
Subtle Medical Receives FDA Clearance for SubtleHD(TM)(PET), Next-Generation AI-Powered Image Acceleration and Enhancement Software
Devices Radiology FDA
 HSMN NewsFeed - 19 May 2026
FRACTURE IDE trial of the Boston Scientific SEISMIQ(TM) 4CE Coronary Intravascular Lithotripsy Catheter Meets Primary Safety and Effectiveness Endpoints
Devices Interventional Cardiology
 HSMN NewsFeed - 12 May 2026
Bayesian Health Receives First-Ever FDA Clearance for Continuous AI Sepsis Monitoring
Devices Monitoring FDA
 HSMN NewsFeed - 11 May 2026
Partner Therapeutics Announces FDA Approval of BIZENGRI(R) (Zenocutuzumab-zbco) for NRG1 Fusion-Positive Cholangiocarcinoma Following Receipt of FDA Commissioner's National Priority Voucher
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 8 May 2026
Harbour BioMed Announces U.S. FDA IND Clearance for HBM7004 for the Treatment of Advanced Solid Tumors
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 5 May 2026
FX Shoulder Solutions, Inc. Receives FDA 510(k) Clearance for FX V135(R) Easytech Shoulder System
Devices Orthopaedic FDA
 HSMN NewsFeed - 30 Apr 2026
Capitan Orthopedics, Inc. Announces Breakthrough Device Designation for its SupraSpacer(TM) Implant
Devices Orthopaedic
 HSMN NewsFeed - 29 Apr 2026
BD Reimagines Central Line Insertion, Advancing Leadership in Patient Safety Through Breakthrough Vascular Access Technology
Devices Product Launch
 HSMN NewsFeed - 28 Apr 2026
Medtronic Announces CE Mark for Stealth AXiS(TM) Surgical System
Devices Surgery Regulatory
 HSMN NewsFeed - 22 Apr 2026
Sonorous Neurovascular Receives FDA 510(k) Clearance for BosCATH(TM) Neurovascular Catheter
Devices Neurology Interventional FDA
 HSMN NewsFeed - 22 Apr 2026
Labcorp Launches FDA-Approved Companion Diagnostic to Identify Patients with Ovarian Cancer Eligible for KEYTRUDA(R)
Diagnostics Oncology FDA
 HSMN NewsFeed - 21 Apr 2026
Invera Medical Reports 12-Month Results From Pilot Trial of Invera Infusion Device Showing Vein Closure in 90% of Patients, Statistically Significant Quality of Life Improvements, and Excellent Safety
Devices Interventional
 HSMN NewsFeed - 17 Apr 2026
Corify Care Receives FDA Clearance for ACORYS(R) -- Introducing Instant, 4-D Electroanatomical Cardiac Mapping in Real-time
Devices Cardiology FDA
 HSMN NewsFeed - 15 Apr 2026
Labcorp Launches FDA-Cleared Fentanyl Test Delivering Results in 10 Minutes
Diagnostics Product Launch FDA
 HSMN NewsFeed - 13 Apr 2026
Lilly's Jaypirca (Pirtobrutinib) Significantly Extended Progression-Free Survival When Added to a Venetoclax Time-Limited Regimen in Patients with Previously Treated CLL/SLL
Biopharmaceuticals Oncology
 HSMN NewsFeed - 8 Apr 2026
MedCAD's AccuStride(R) Receives FDA 510(k) Clearance for New Anatomical Lower Leg Region Tib/Fib Solution
Devices Orthopaedic FDA
 HSMN NewsFeed - 8 Apr 2026
Stealth BioTherapeutics Appoints David A. Brown, Ph.D., as Chief Scientific Officer to Advance the Company's Pioneering Work in Mitochondrial Medicine
Biopharmaceuticals Personnel
 HSMN NewsFeed - 6 Apr 2026
Neurocrine to Acquire Soleno Therapeutics, Expanding Its Endocrinology and Rare Disease Portfolio
Biopharmaceuticals Mergers & Acquisitions
 HSMN NewsFeed - 2 Apr 2026
Zeto Announces FDA 510(k) Clearance of Zeto New Wave(TM), Advancing Efficiency in Outpatient EEG
Devices FDA
 HSMN NewsFeed - 1 Apr 2026
Nanoscope Therapeutics Appoints Ophthalmology Industry Veteran Paul Hallen as Chief Operating Officer to Advance Global Commercial Readiness
Biopharmaceuticals Ophthalmology Personnel
 HSMN NewsFeed - 31 Mar 2026
Lilly to Acquire Centessa Pharmaceuticals to Advance Treatments for Sleep-Wake Disorders
Biopharmaceuticals Mergers & Acquisitions
 HSMN NewsFeed - 31 Mar 2026
SirPAD: Primary Results Confirm the Safety and Efficacy of Sirolimus Coated Balloon in PAD
Devices Interventional Cardiology
 HSMN NewsFeed - 30 Mar 2026
Boston Scientific receives FDA clearance for the Asurys(TM) Fluid Management System
Devices Surgery FDA
 HSMN NewsFeed - 27 Mar 2026
Otsuka Pharmaceutical to Acquire Transcend Therapeutics
Biopharmaceuticals Mergers & Acquisitions
 HSMN NewsFeed - 25 Mar 2026
IceCure Reports Positive 5-Year Top-Line Results from ICESECRET Kidney Cancer Cryoablation Study: 89.4% and 83.9% Recurrence-Free Rates
Devices Interventional Oncology
 HSMN NewsFeed - 24 Mar 2026
Bridge to Life Announces First Commercial Use of VitaSmart(TM) Hypothermic Oxygenated Perfusion (HOPE) System by Major U.S. Transplant Center Following FDA Clearance, Signaling Early Physician Confidence
Devices Surgery
 HSMN NewsFeed - 20 Mar 2026
Co-Diagnostics Signs Agreement to Significantly Expand Commercial and Distribution Territory Across South Asia
Diagnostics Distribution
 HSMN NewsFeed - 19 Mar 2026
Carecubes Closes $6.5 Million Series A to Transform Infectious Disease Response
Devices Venture Capital
 HSMN NewsFeed - 18 Mar 2026
Spinal Elements Expands Ventana(R) Platform with FDA 510(k) Clearance and First Cases of Ventana(R) A ALIF System
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 12 Mar 2026
Ratio Therapeutics Appoints Global Medical Leader Colin Hayward as Chief Medical Officer
Biopharmaceuticals Personnel
 HSMN NewsFeed - 11 Mar 2026
ARTHEx Biotech Granted FDA Fast Track Designation for ATX-01 for the Treatment of Myotonic Dystrophy Type 1 (DM1)
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 9 Mar 2026
Baird Medical Accelerates U.S. Expansion in Interventional Thyroidology at NASIT 2026
Devices Interventional
 HSMN NewsFeed - 6 Mar 2026
U.S. FDA Approves TECVAYLI(R) in Combination with DARZALEX FASPRO(R) for Relapsed/Refractory Multiple Myeloma
Biopharmaceuticals Oncology Drug Delivery FDA
 HSMN NewsFeed - 5 Mar 2026
Mitria Medical Announces First Use of Novel Mitral Valve Repair Device in U.S. Under Single Patient Expanded Access
Devices Cardiology Interventional
 HSMN NewsFeed - 4 Mar 2026
First-in-Human Use of CereVasc(R) eShunt(R) System in Idiopathic Intracranial Hypertension Demonstrates Sustained Clinical Outcomes
Devices Neurosurgery
 HSMN NewsFeed - 26 Feb 2026
Brainstorm Cell Therapeutics Secures Second $1 Million Strategic Placement; Total $2 Million Raised In February
Regenerative Medicine Neurology Venture Capital
 HSMN NewsFeed - 25 Feb 2026
Vanda Pharmaceuticals Announces FDA Acceptance of Biologics License Application Filing for Imsidolimab for the Treatment of Generalized Pustular Psoriasis
Biopharmaceuticals FDA
 HSMN NewsFeed - 24 Feb 2026
Brainomix Extends Series C Financing to $25.4M (£18.8M) to Support U.S. Expansion
Devices Radiology Venture Capital
 HSMN NewsFeed - 20 Feb 2026
Brainstorm Cell Therapeutics Announces $1 Million Strategic Financing at Premium to Market
Regenerative Medicine Neurology Venture Capital
 HSMN NewsFeed - 19 Feb 2026
Altesa BioSciences Closes Oversubscribed $75 Million Series B Financing to Transform Treatment of Chronic Lung Diseases
Biopharmaceuticals Venture Capital
 HSMN NewsFeed - 18 Feb 2026
Synchrony Medical Secures $5M Funding to Fuel Commercial Expansion of its At-Home Airway Clearance Device for Chronic Respiratory Disease
Devices Venture Capital
 HSMN NewsFeed - 17 Feb 2026
Medtronic Announces First Surgery With Hugo(TM) Robotic-Assisted Surgery System In the U.S. Performed at Cleveland Clinic
Devices Surgery
 HSMN NewsFeed - 12 Feb 2026
Bracco and ACIST Medical Systems Announce European Launch of ACIST Pro(TM) Diagnostic System
Diagnostics Interventional Product Launch
 HSMN NewsFeed - 11 Feb 2026
Labcorp Launches First FDA-Cleared Blood Test for Alzheimer's Disease Assessment in Primary Care
Diagnostics Neurology Product Launch
 HSMN NewsFeed - 10 Feb 2026
Vesalio Expands International Neurovascular Portfolio with CE Mark of NeVa VS and NeVa 3.0 mm and Receives Additional FDA 510(k) Clearance for its Aspiration Catheters
Devices Neurology Interventional Regulatory
 HSMN NewsFeed - 4 Feb 2026
Stratus Medical Raises $10 million Series B to Complete Development of New Technology and Fund Clinical Trial
Devices Venture Capital
 HSMN NewsFeed - 3 Feb 2026
Industry Veteran and Med Tech Pioneer Appointed Special Advisor to ProVerum
Devices Urology Personnel
 HSMN NewsFeed - 29 Jan 2026
FDA Qualifies MolecuLightDX Wound Measurement as a Medical Device Development Tool (MDDT) for Evaluating New Products in Wound Care
Devices Wound Care FDA
 HSMN NewsFeed - 28 Jan 2026
REGENXBIO Announces Regulatory Update on Ultra Rare MPS Programs
Regenerative Medicine FDA
 HSMN NewsFeed - 26 Jan 2026
StemCyte Announces FDA Clearance of Expanded Access Program for RegeneCyte(R) (HPC, Cord Blood) to Address Unmet Need in Long COVID
Regenerative Medicine FDA
 HSMN NewsFeed - 23 Jan 2026
Affera(TM) momentum continues as Medtronic announces CE Mark in Europe and U.S. IDE First Cases for Sphere-360™ PFA Catheter to Treat Paroxysmal Atrial Fibrillation
Devices Interventional Cardiology Regulatory
 HSMN NewsFeed - 21 Jan 2026
ProVerum Announces First Commercial Cases Completed with the ProVee(R) System for BPH
Devices Urology
 HSMN NewsFeed - 19 Jan 2026
FDA Grants Regenerative Medicine Advanced Therapy (RMAT) Designation to iRegene's NouvNeu001, Making It the World's First iPSC Therapy with Both FTD and RMAT Recognitions
Regenerative Medicine Neurology FDA
 HSMN NewsFeed - 15 Jan 2026
BD Receives FDA 510(k) Clearance for EnCor EnCompass(TM) Breast Biopsy and Tissue Removal System
Devices FDA
 HSMN NewsFeed - 14 Jan 2026
GT Medical Technologies Announces First Patients Treated with GammaTile in the BRIDGES Trial for Newly Diagnosed Glioblastoma
Devices Neurosurgery Oncology
 HSMN NewsFeed - 13 Jan 2026
MolecuLight Files ITC Complaint to Block Unlawful Importation of Infringing Fluorescence Bacteria Imaging Products
Devices Wound Care
 HSMN NewsFeed - 12 Jan 2026
Neurolief receives FDA PMA Approval for First At-Home Brain Neuromodulation Therapy for Adults Whose Depression Was Not Adequately Improved by Antidepressants
Devices Neurology FDA
 HSMN NewsFeed - 9 Jan 2026
Haemonetics Acquires Vivasure Medical Limited
Devices Interventional Mergers & Acquisitions
 HSMN NewsFeed - 8 Jan 2026
Saluda Medical Receives Regulatory Approval for EVA(TM) Sensing Technology in Europe with recognition in Australia
Devices Neurology Regulatory
 HSMN NewsFeed - 5 Jan 2026
ScinoPharm Secures U.S. FDA Approval for Glatiramer Acetate Injection for the Treatment of Multiple Sclerosis
Biopharmaceuticals Generics Neurology FDA
 HSMN NewsFeed - 30 Dec 2025
HAI Solutions Receives FDA De Novo Grant for QIKCAP System: Pioneering UVC Technology for Microbial Reduction on Needleless IV Connectors
Devices FDA
 HSMN NewsFeed - 29 Dec 2025
FDA Accepts for Review INOVIO's BLA for INO-3107 for the Treatment of Adults with Recurrent Respiratory Papillomatosis (RRP)
Biopharmaceuticals FDA
 HSMN NewsFeed - 23 Dec 2025
Zydus Partners with Bioeq for U.S. Commercialisation rights for NUFYMCO(R), an Interchangeable Biosimilar to Lucentis(R)
Biopharmaceuticals Licensing
 HSMN NewsFeed - 22 Dec 2025
U.S. FDA Approves JASCAYD(R) (nerandomilast) Tablets for the Treatment of Progressive Pulmonary Fibrosis in Adults
Biopharmaceuticals FDA
 HSMN NewsFeed - 19 Dec 2025
BioMarin to Acquire Amicus Therapeutics for $4.8 Billion, Expanding Position as a Leader in Rare Diseases, Accelerating Revenue Growth and Strengthening Financial Outlook
Biopharmaceuticals Mergers & Acquisitions
 HSMN NewsFeed - 17 Dec 2025
GT Medical Technologies Welcomes New GammaTile(R) Center of Excellence Program Designation
Devices Neurosurgery Oncology
 HSMN NewsFeed - 16 Dec 2025
Zimmer Biomet, OneStep Collaborate to Provide Enhanced Mobility Data to Patients and Surgeons to Help Improve Joint Procedure Recovery
Devices Orthopaedic
 HSMN NewsFeed - 11 Dec 2025
Vesalio Receives FDA 510(k) Clearance of enVast, the First Stent-Based Coronary Thrombectomy Technology
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 11 Dec 2025
NexGen Hyperbaric Expands National Presence to Florida, Adds New Professional Sports Customer, and Announces Flagship Facility Launch
Devices
 HSMN NewsFeed - 10 Dec 2025
Expression Therapeutics Appoints Industry Veteran Dr. David Townson as Chief Executive Officer
Biopharmaceuticals Personnel
 HSMN NewsFeed - 10 Dec 2025
CathVision Announces Appointment of Eric Thepaut as Independent Chairman of the Board and Releases ECGenius(R) System Version 3.5
Devices Cardiology Product Launch Personnel
 HSMN NewsFeed - 8 Dec 2025
EyeYon Medical Ltd. Receives FDA IDE Approval to Initiate U.S. Clinical Study of EndoArt(R), the First Artificial Endothelial Layer for Corneal Edema
Devices Ophthalmology FDA
 HSMN NewsFeed - 2 Dec 2025
CMS Finalizes OPPS Payment for Eko Health's SENSORA(R) Platform, Expanding Reimbursement for AI-Enabled Cardiac Disease Detection in Hospital-Associated Outpatient Care
Devices Cardiology Reimbursement
 HSMN NewsFeed - 28 Nov 2025
Vanda Pharmaceuticals Provides Regulatory Update on Tradipitant for Motion Sickness
Biopharmaceuticals FDA
 HSMN NewsFeed - 25 Nov 2025
Medicare Finalizes Reimbursement for Caristo's CaRi-Plaque(TM) Across Hospital and Office Settings
Diagnostics Cardiology Reimbursement
 HSMN NewsFeed - 20 Nov 2025
Aspen Neuroscience Announces $115 Million Series C Financing to Accelerate Personalized Cell Therapy Programs
Biopharmaceuticals Regenerative Medicine Venture Capital
 HSMN NewsFeed - 18 Nov 2025
Piccolo Medical(R) Receives FDA Clearance to Expand ECGuide(TM) Technology Use to Pediatric and Neonatal Patients
Devices FDA
 HSMN NewsFeed - 14 Nov 2025
Zimmer Biomet Receives U.S. FDA Clearance for Enhanced Version of ROSA(R) Knee Robotic Technology
Devices Orthopaedic FDA
 HSMN NewsFeed - 13 Nov 2025
icotec Receives FDA Clearance for the CMORE(R) CT System, Expanding its BlackArmor(R) Engineered Carbon/PEEK Technology to the Posterior Cervicothoracic Spine
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 12 Nov 2025
Modulight Biotherapeutics Announces $12 Million Seed Funding for Novel Optogenetic Therapy to Treat Neurological Disorders
Devices Neurology Venture Capital
 HSMN NewsFeed - 10 Nov 2025
Freenome Appoints Industry Veteran Rob Guigley as Chief Commercial Officer to Drive Commercial Strategy, As Agreement with Exact Sciences Clears Antitrust Review
Diagnostics Personnel
 HSMN NewsFeed - 7 Nov 2025
Laborie Announces Agreement to Acquire the JADA(R) System from Organon
Devices Acquisitions
 HSMN NewsFeed - 6 Nov 2025
GT Medical Technologies Welcomes New GammaTile(R) Center of Excellence Program Designation
Devices Neurosurgery Oncology
 HSMN NewsFeed - 6 Nov 2025
Amber Implants Appoints Vincent Gardès as Chief Executive Officer to Drive Commercial Launch of VCFix(R) Spinal System
Devices Orthopaedic Neurosurgery Personnel
 HSMN NewsFeed - 5 Nov 2025
Volta Medical Brings Volta AF-Xplorer(TM) II to the U.S., Ushering in a New Era of AI in Ablation for Complex Atrial Fibrillation
Devices Interventional Cardiology Product Launch
 HSMN NewsFeed - 3 Nov 2025
Alcresta Therapeutics Announces FDA Clearance for Expanded Use of RELiZORB(R) (iMMOBILIZED LIPASE) Cartridge for Neonates and Infants
Biopharmaceuticals FDA
 HSMN NewsFeed - 28 Oct 2025
Zimmer Biomet Announces FDA Breakthrough Designation for World's First Iodine-Treated Total Hip Replacement System
Devices Orthopaedic FDA
 HSMN NewsFeed - 24 Oct 2025
Terumo Interventional Systems Announces Its New OPUSWAVE(R) Dual Sensor Imaging System and DualView(R) Imaging Catheter Receive FDA 510(k) Clearance
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 23 Oct 2025
Labcorp to Offer First FDA-Cleared Blood Test to Rule out Alzheimer's-Related Amyloid Pathology in Primary Care Settings
Diagnostics Neurology
 HSMN NewsFeed - 21 Oct 2025
Onkos Surgical(R) Receives FDA 510(k) Clearance for ELEOS(TM) Proximal Tibia with NanoCept(R) Antibacterial Technology
Devices Orthopaedic FDA
 HSMN NewsFeed - 21 Oct 2025
PleoPharma, Inc. Closes $36 Million Series B Financing Round
Biopharmaceuticals Venture Capital
 HSMN NewsFeed - 15 Oct 2025
CAPS Medical's PlasmaSure(TM) Receives FDA Breakthrough Device Designation
Devices Oncology FDA
 HSMN NewsFeed - 13 Oct 2025
Zeta Surgical(R) AI-powered TMS Navigation System Receives FDA 510(k) Clearance
Devices Neurology FDA
 HSMN NewsFeed - 10 Oct 2025
Next-Generation AI-Driven SyncAR(R) Spine Receives FDA Clearance for Spine Surgery
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 6 Oct 2025
Alcresta Therapeutics Expands Executive Leadership to Drive Strategic Initiatives
Biopharmaceuticals Personnel
 HSMN NewsFeed - 3 Oct 2025
Koh Young to Showcase Next Gen Navigated Neurosurgical Robot at CNS Innovation Symposium
Devices Neurosurgery
 HSMN NewsFeed - 1 Oct 2025
Revance Expands Leadership Team with Key Executive Appointments
Devices Dermatology Personnel
 HSMN NewsFeed - 30 Sep 2025
Natus Acquires Holberg EEG, Expanding Innovation in Neurodiagnostic AI Solutions
Devices Diagnostics Neurology Mergers & Acquisitions
 HSMN NewsFeed - 29 Sep 2025
Novo Nordisk Resubmits Awiqli(R) to the FDA With Potential to be the First Once-Weekly Basal Insulin Treatment for Adults with Type 2 Diabetes
Biopharmaceuticals Endocrinology FDA
 HSMN NewsFeed - 25 Sep 2025
Sanolla Launches the World's First Smart AI-powered Stethoscope Offering Full-Spectrum Auscultation
Devices Product Launch
 HSMN NewsFeed - 24 Sep 2025
TSC Life Receives FDA 510(K) Clearance for Fluido(R) AirGuard System, a Moderate to High Flow Blood and IV Fluid Warming Solution for the Prevention of Hypothermia
Devices FDA
 HSMN NewsFeed - 22 Sep 2025
Mallinckrodt Names Dr. Marek J. Honczarenko as EVP and Chief Scientific Officer
Biopharmaceuticals Personnel
 HSMN NewsFeed - 19 Sep 2025
Kelyniam Global, Inc. Receives FDA Clearance for Innovative Fusion(TM) BCP-PEEK Implant
Devices Neurosurgery FDA
 HSMN NewsFeed - 18 Sep 2025
J & D Pharmaceuticals LLC Receives Orphan Drug Designation for Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Biopharmaceuticals FDA
 HSMN NewsFeed - 17 Sep 2025
Amber Implants Secures FDA 510(k) Clearance for VCFix(R) Spinal System: A Next-Generation Solution for Vertebral Compression Fractures
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 10 Sep 2025
Levita Magnetics Powers World's First AI-Guided Autonomous Surgery with MARS Platform
Devices Surgery
 HSMN NewsFeed - 9 Sep 2025
ARTBIO Announces FDA Clearance of IND Application for Lead Alpha Radioligand Therapy AB001
Devices Oncology FDA
 HSMN NewsFeed - 8 Sep 2025
FDA Accepts Letter of Intent to Qualify LSM by VCTE (FibroScan(R)) as First Non-Invasive Surrogate Endpoint in MASH Clinical Trials
Diagnostics FDA
 HSMN NewsFeed - 4 Sep 2025
Sentec Receives FDA Clearance for LuMon(TM) Electrical Impedance Tomography (EIT) System -- First EIT System Indicated for Premature Infants and for Spontaneously Breathing Patients in the United States
Devices Monitoring FDA
 HSMN NewsFeed - 4 Sep 2025
4DMedical's CT:VQ(TM) Receives FDA 510(k) Clearance; First-and-Only CT-Based VQ Technology
Devices Radiology FDA
 HSMN NewsFeed - 2 Sep 2025
Servier and IDEAYA Biosciences Partner to Bring Darovasertib, a Promising Uveal Melanoma Treatment, to Patients Worldwide
Biopharmaceuticals Oncology Licensing
 HSMN NewsFeed - 27 Aug 2025
Large Independent Randomized Controlled Trial Validates MolecuLight's Transformative Impact on Wound Debridement, Showing Improved Outcomes and Lower Costs
Devices Wound Care
 HSMN NewsFeed - 21 Aug 2025
FDA Clearance of Salix(R) Coronary Plaque Module
Devices Cardiology FDA
 HSMN NewsFeed - 20 Aug 2025
CytoSorbents Updates U.S. FDA Regulatory Status of DrugSorb-ATR
Devices FDA
 HSMN NewsFeed - 18 Aug 2025
Labcorp Launches First FDA-Cleared Blood Test for Alzheimer's Disease
Diagnostics Neurology Product Launch
 HSMN NewsFeed - 15 Aug 2025
Precigen Announces Full FDA Approval of PAPZIMEOS (zopapogene imadenovec-drba), the First and Only Approved Therapy for the Treatment of Adults with Recurrent Respiratory Papillomatosis
Biopharmaceuticals FDA
 HSMN NewsFeed - 13 Aug 2025
BTL Expands EMFACE(R) Indications with New FDA Clearance for TMJ Dysfunction
Devices FDA
 HSMN NewsFeed - 11 Aug 2025
NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Granted FDA Fast Track Designation for NRX-100 for Suicidal Ideation in Patients with Depression, including Bipolar Depression
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 5 Aug 2025
Hemispherian Receives FDA IND Clearance for First-in-Class Glioblastoma Therapeutic, GLIX1
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 31 Jul 2025
Ultromics Lands $55M Series C to Tackle Undiagnosed Heart Failure at Scale
Devices Cardiology Venture Capital
 HSMN NewsFeed - 30 Jul 2025
BD Receives FDA 510(k) Clearance for Rapid Point-of-Care COVID-19 Test
Diagnostics FDA
 HSMN NewsFeed - 30 Jul 2025
MAGENTIQ EYE Secures Series A Investment Led by aMoon to Drive the Future of AI-Powered Gastroenterology
Devices Gastroenterology Venture Capital
 HSMN NewsFeed - 29 Jul 2025
Leo Cancer Care Receives FDA 510(k) Clearance for Marie(R) - A Revolutionary Upright Radiotherapy Platform
Devices Oncology FDA
 HSMN NewsFeed - 24 Jul 2025
GT Medical Technologies Welcomes New GammaTile(R) Center of Excellence Program Designation
Devices Oncology Neurosurgery
 HSMN NewsFeed - 23 Jul 2025
Neuros Medical Announces First Commercial Implant of the Altius(R) Direct Electrical Nerve Stimulation System, a Breakthrough Non-Opioid Treatment for Chronic Post-Amputation Pain
Devices Neurology FDA
 HSMN NewsFeed - 23 Jul 2025
BD Announces First Pharma-Sponsored Clinical Trial Using BD Libertas(TM) Wearable Injector Technology for Biologic Drugs
Biopharmaceuticals Drug Delivery
 HSMN NewsFeed - 22 Jul 2025
SPRITAM(R) (levetiracetam) Tablets for Oral Suspension Approved by FDA for Nasogastric and Gastrostomy Tube Administration
Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 17 Jul 2025
Saluda Medical Announces Full U.S. Launch of EVA(TM) Sensing Technology for Use with the Evoke(R) SmartLoop(TM) System
Devices Neurology Product Launch
 HSMN NewsFeed - 16 Jul 2025
Piccolo Medical, Inc. Receives FDA Clearance for 2nd Generation SmartPICC(R) Technology
Devices FDA
 HSMN NewsFeed - 15 Jul 2025
GT Medical Technologies Completes Final Close of Company's Oversubscribed $53 Million Series D Equity Financing to Advance Commercial Treatment for Patients with Operable Brain Tumors
Devices Neurosurgery Oncology Venture Capital
 HSMN NewsFeed - 14 Jul 2025
Zimmer Biomet Announces Definitive Agreement to Acquire Monogram Technologies, Expanding Robotics Suite with Autonomous Solutions
Devices Orthopaedic Mergers & Acquisitions
 HSMN NewsFeed - 11 Jul 2025
Tomoverse Imaging Inc. Announces Closing of $5 Million Dollar Seed Funding Round Led by Strategic Canadian Family Office
Devices Radiology Cardiology Venture Capital
 HSMN NewsFeed - 10 Jul 2025
Klotho Neurosciences, Inc. Granted FDA Orphan Drug Designation for KLTO-202 for Treatment of Amyotrophic Lateral Sclerosis ("ALS" or "Lou Gehrig's Disease")
Regenerative Medicine Neurology FDA
 HSMN NewsFeed - 9 Jul 2025
Neuros Medical Secures $56M Series D to Commercialize the Altius(R) System, an FDA-Approved, Non-Opioid Nerve Stimulation System for Chronic Post-Amputation Pain
Devices Venture Capital
 HSMN NewsFeed - 8 Jul 2025
Soligenix Corporate Update Letter - Key Highlights and Upcoming Milestones
Biopharmaceuticals Oncology
 HSMN NewsFeed - 7 Jul 2025
Boston Scientific Receives FDA Approval for Expanded Labeling of FARAPULSE(TM) Pulsed Field Ablation System
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 3 Jul 2025
Novartis Provides Update on Phase III GCAptAIN Study of Cosentyx(R) in Giant Cell Arteritis (GCA)
Biopharmaceuticals
 HSMN NewsFeed - 2 Jul 2025
Moon Surgical Receives FDA Clearance for Maestro(TM) Connectivity and Predetermined Change Control Plan for AI-Powered ScoPilot(R)
Devices Surgery FDA
 HSMN NewsFeed - 30 Jun 2025
Oncolytics Biotech(R) Appoints Former Ambrx Executive as Chief Business Officer to Drive Business Development Strategy
Biopharmaceuticals Oncology Personnel
 HSMN NewsFeed - 24 Jun 2025
Ascidian Therapeutics Appoints Dr. Murray A. Abramson as Chief Development Officer and Establishes Ophthalmology Clinical Advisory Board to Advance ACDN-01 for Treatment of Stargardt Disease
Biopharmaceuticals Ophthalmology Personnel
 HSMN NewsFeed - 23 Jun 2025
Sephience(TM) (sepiapterin) Granted Marketing Authorization by the European Commission for the Treatment of Children and Adults Living with Phenylketonuria (PKU)
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 20 Jun 2025
Lomond Therapeutics Announces U.S. FDA Clearance of IND Application for Lonitoclax, a Selective BCL2 Inhibitor with Limited Immune Suppression and Improved Safety Compared to Venetoclax and Venetoclax- Like Molecules
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 17 Jun 2025
Corvia Medical Closes $55 Million Funding Round to Complete Confirmatory Trial and Pursue FDA Approval of Corvia Atrial Shunt
Devices Cardiology Venture Capital
 HSMN NewsFeed - 13 Jun 2025
U.S. Food & Drug Administration (FDA) Approves Investigational New Drug (IND) Application for Myrio's Lead Product (PHOX2B PC-CAR T) for the Treatment of Neuroblastoma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 12 Jun 2025
MolecuLight(R) Imaging Significantly Improves Outcomes and Cuts Costs for Deep Sternal Wound Infections in Taiwan Study; Signals Expansion into Surgical Applications
Devices Wound Care
 HSMN NewsFeed - 11 Jun 2025
SpliceBio Secures $135 Million Series B Financing to Advance Lead Program SB-007 in Stargardt Disease and Expand Pipeline of Genetic Medicines
Regenerative Medicine Ophthalmology Venture Capital
 HSMN NewsFeed - 10 Jun 2025
Cristcot Appoints Richard Kim as Chief Commercial Officer
Biopharmaceuticals Gastroenterology Personnel
 HSMN NewsFeed - 9 Jun 2025
TYBR Health Announces FDA 510(k) Clearance for B3 GEL(TM) System, a Flowable Bio-Gel to Protect Healing Tissue and Preserve Function
Devices Regenerative Medicine Surgery FDA
 HSMN NewsFeed - 5 Jun 2025
Penumbra Introduces the Ruby(R) XL System - the Longest, Largest, and Softest Coil on the Market for Vascular Embolization
Devices Interventional FDA Product Launch
 HSMN NewsFeed - 3 Jun 2025
Amber Implants Announces Successful One-Year Follow-Up Data in First-in-Human Clinical Trial of VCFix(R) Spinal System
Devices Orthopaedic Neurosurgery
 HSMN NewsFeed - 2 Jun 2025
Sanofi to Acquire Blueprint Medicines, Expanding Portfolio in Rare Immunological Disease and Adding Early-stage Pipeline in Immunology
Biopharmaceuticals Mergers & Acquisitions
 HSMN NewsFeed - 30 May 2025
Diakonos Oncology Closes $20 Million Financing to Accelerate Phase 2 Glioblastoma Clinical Development Program and Expand Use of Innovative Dendritic Cell Platform for Studies in Other Indications
Biopharmaceuticals Oncology Venture Capital
 HSMN NewsFeed - 29 May 2025
First in human use of Remanufactured da Vinci Xi(R) Robotic Instruments
Devices Surgery
 HSMN NewsFeed - 27 May 2025
BrainStorm Secures Key Manufacturing Partnership with Minaris for Upcoming NurOwn(R) Phase 3b ALS Clinical Trials
Regenerative Medicine Neurology
 HSMN NewsFeed - 20 May 2025
Ritedose Pharmaceuticals Receives FDA Approval for Albuterol Sulfate Inhalation Solution, 0.5% (2.5 mg/0.5 mL)*--Addressing Nationwide Shortage of the Essential Drug
Biopharmaceuticals FDA
 HSMN NewsFeed - 19 May 2025
BrainStorm Receives FDA Clearance to Initiate Phase 3b Trial of NurOwn(R) for ALS
Regenerative Medicine Neurology FDA
 HSMN NewsFeed - 19 May 2025
Trax Surgical Receives FDA 510(k) Clearance for Nitinol Staple System
Devices Orthopaedic FDA
 HSMN NewsFeed - 14 May 2025
GT Medical Technologies Welcomes New GammaTile(R) Center of Excellence Program Designation
Devices Neurosurgery Oncology
 HSMN NewsFeed - 9 May 2025
FDA Approves Teal Health's Teal Wand(TM)--The First and Only At-Home Self-Collection Device for Cervical Cancer Screening, Introducing a Comfortable Alternative to In-Person Screening
Devices Diagnostics FDA
 HSMN NewsFeed - 6 May 2025
Leo Cancer Care Particle Therapy Solution Marie is Now 510(k) Pending
Devices Oncology FDA
 HSMN NewsFeed - 5 May 2025
Spinogenix Announces FDA-Authorized Expanded Access Program for SPG302, the First Synaptic Regenerative Therapy to Treat ALS
Biopharmaceuticals Regenerative Medicine Neurology FDA
 HSMN NewsFeed - 1 May 2025
Altesa BioSciences announces Katharine Knobil, M.D. as Chief Medical Officer
Biopharmaceuticals Personnel
 HSMN NewsFeed - 29 Apr 2025
Lutris Pharma Announces the Appointment of Seasoned Life Science Executive, Sumant Ramachandra, M.D., Ph.D., as Chief Executive Officer
Biopharmaceuticals Personnel
 HSMN NewsFeed - 25 Apr 2025
FDA Clears New Clarius Prostate AI To Help Physicians Assess and Diagnose Common Urologic Conditions in Minutes
Devices Urology FDA
 HSMN NewsFeed - 24 Apr 2025
Medtronic Advances Abbott CGM Partnership with FDA Submission of Interoperable Insulin Pump
Devices Endocrinology FDA
 HSMN NewsFeed - 21 Apr 2025
FDA Grants Orphan Drug Designation to NS-229 for the Treatment of Eosinophilic Granulomatosis with Polyangiitis
Biopharmaceuticals FDA
 HSMN NewsFeed - 14 Apr 2025
CytoSorbents Appoints Thomas Shannon as Vice President of Marketing for North America
Devices Personnel
 HSMN NewsFeed - 11 Apr 2025
Turbett Surgical Receives FDA 510(k) Clearance for Enhanced Instrument Pod Portfolio
Devices Surgery FDA
 HSMN NewsFeed - 10 Apr 2025
BrainStorm Cell Therapeutics Submits IND Amendment to FDA, Paving the Way for Phase 3b Trial of NurOwn(R) in ALS
Regenerative Medicine Neurology FDA
 HSMN NewsFeed - 8 Apr 2025
Brainomix Advances Stroke Care with Landmark FDA Clearance
Devices Neurology FDA
 HSMN NewsFeed - 7 Apr 2025
ICU Medical Introduces Its New Category of Infusion Devices With FDA Clearances of Plum Solo(TM) and Plum Duo(TM) Precision IV Pumps
Devices Drug Delivery FDA
 HSMN NewsFeed - 4 Apr 2025
Neurocrine Biosciences Appoints Dr. Sanjay Keswani as Chief Medical Officer
Biopharmaceuticals Neurology Personnel
 HSMN NewsFeed - 3 Apr 2025
Study Links Bacterial Load to Pain in Venous Ulcers, Demonstrating Effective Reduction with MolecuLight
Devices Wound Care
 HSMN NewsFeed - 27 Mar 2025
Pharmaceutical Industry Veteran, Ashish Patel, PhD, Joins Nanoscope as Senior Vice President of Sales and Marketing
Regenerative Medicine Ophthalmology Personnel
 HSMN NewsFeed - 26 Mar 2025
Supira Medical Secures $120M Oversubscribed Series E Financing and Completes Enrollment of SUPPORT I Early Feasibility Study in the United States
Devices Interventional Cardiology Venture Capital
 HSMN NewsFeed - 25 Mar 2025
Hubble Therapeutics Closes Series A Financing to Develop Gene Therapy Cure for LCA16
Biopharmaceuticals Ophthalmology Venture Capital
 HSMN NewsFeed - 24 Mar 2025
Newronika Receives CE Mark Approval for AlphaDBS, Advancing Adaptive Deep Brain Stimulation for Parkinson's Disease
Devices Neurology Regulatory
 HSMN NewsFeed - 17 Mar 2025
Surf Bio Appoints Industry Veteran Doug Hecker as Head of Technical Operations
Biopharmaceuticals Drug Delivery Personnel
 HSMN NewsFeed - 12 Mar 2025
Vivace Therapeutics Raises $35 Million in Series D Financing to Support Clinical Development of First-in-Class Cancer Drug Targeting the Hippo Pathway
Biopharmaceuticals Oncology Venture Capital
 HSMN NewsFeed - 7 Mar 2025
Zimmer Biomet Receives FDA Clearance for Persona(R) Revision SoluTion(TM) Femur
Devices Orthopaedic FDA
 HSMN NewsFeed - 5 Mar 2025
Jazz Pharmaceuticals to Acquire Chimerix, Further Diversifying Oncology Portfolio
Biopharmaceuticals Oncology Mergers & Acquisitions
 HSMN NewsFeed - 26 Feb 2025
ABANZA Receives FDA 510(k) Clearance for WasherCap(TM) Mini Implantable Fixation Device
Devices Orthopaedic FDA
 HSMN NewsFeed - 24 Feb 2025
IceCure Submits Filing for Regulatory Approval of its Next-Generation XSense(TM) Cryoablation System in Israel
Devices Oncology Regulatory
 HSMN NewsFeed - 21 Feb 2025
FDA Declares Wegovy(R) and Ozempic(R) Shortage is Over and that Novo Nordisk is Fully Meeting or Exceeding Nationwide Demand for All Doses
Biopharmaceuticals FDA
 HSMN NewsFeed - 20 Feb 2025
Valencia Technologies Announces Strategic Investment of up to $35 Million and Appointment of James D. Surek as Chief Executive Officer
Devices Personnel Venture Capital
 HSMN NewsFeed - 18 Feb 2025
Oncolytics Biotech(R) Strengthens Its Pipeline in 2025 with Key Pancreatic and Anal Cancer Advances in Addition to Metastatic Breast Cancer
Biopharmaceuticals Oncology
 HSMN NewsFeed - 13 Feb 2025
Roche Elecsys sFlt-1/PlGF Ratio for Preeclampsia Receives FDA 510(k) Clearance, Offering a Fast and Raliable Way to Predict the Risk of Developing Severe Preeclampsia
Diagnostics FDA
 HSMN NewsFeed - 11 Feb 2025
Neuvotion Receives FDA Clearance for NeuStim(TM) Providing Non-Invasive, High-Resolution Stimulation for the Hand After Stroke or Spinal Cord Injury
Devices Neurology FDA
 HSMN NewsFeed - 10 Feb 2025
Nektar Therapeutics Receives Fast Track Designation for Rezpegaldesleukin for the Treatment of Moderate-to-Severe Atopic Dermatitis
Biopharmaceuticals Dermatology FDA
 HSMN NewsFeed - 7 Feb 2025
Most Patients on Lilly's Omvoh(R) (mirikizumab-mrkz) for Crohn's Disease Achieved Sustained Clinical Remission and Endoscopic Response at Two Years
Biopharmaceuticals Gastroenterology
 HSMN NewsFeed - 5 Feb 2025
Newronika Receives Investigational Device Exemption (IDE) from FDA to Initiate U.S. Clinical Trial of Adaptive DBS System
Devices Neurology FDA
 HSMN NewsFeed - 31 Jan 2025
U.S. FDA Approves Celltrion's AVTOZMA(R) (tocilizumab-anoh), a Biosimilar to ACTEMRA(R)
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 30 Jan 2025
Coeptis Therapeutics Holdings Becomes COEPTIS: Embracing a Future of Technology and Innovation
Biopharmaceuticals Mergers & Acquisitions
 HSMN NewsFeed - 28 Jan 2025
AI Optics Receives FDA Clearance, Increasing Patient Access to Retinal Screening
Devices Ophthalmology FDA
 HSMN NewsFeed - 17 Jan 2025
FDA Approves LUMAKRAS(R) (Sotorasib) in Combination with Vectibix(R) (Panitumumab) for Chemorefractory KRAS G12C-Mutated Metastatic Colorectal Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 16 Jan 2025
UCB Announces U.S. Availability of 320 mg/2 mL Single-Injection Administration Option for BIMZELX(R) (bimekizumab-bkzx)
Biopharmaceuticals Drug Delivery Product Launch
 HSMN NewsFeed - 15 Jan 2025
New Drug Application Initiated with U.S. FDA for TAR-200, the First and Only Intravesical Drug Releasing System for Patients with BCG-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer
Biopharmaceuticals Drug Delivery Oncology FDA
 HSMN NewsFeed - 13 Jan 2025
Cresilon Announces U.S. Nationwide Launch of TRAUMAGEL
Devices FDA
 HSMN NewsFeed - 13 Jan 2025
Medtronic Achieves CE Mark Approval for BrainSense Adaptive Deep Brain Stimulation and Electrode Identifier, a Groundbreaking Advance In Personalized, Sensing-Enabled Care for People with Parkinson's Through Innovative Brain-Computer Interface Technology
Devices Neurosurgery Regulatory
 HSMN NewsFeed - 13 Jan 2025
Roche receives FDA clearance for new, highly-sensitive test to aid clinicians in diagnosing B-cell lymphoma
Diagnostics Oncology FDA
 HSMN NewsFeed - 8 Jan 2025
Johnson & Johnson's Posdinemab and Tau Active Immunotherapy Receive U.S. FDA Fast Track Designations for the Treatment of Alzheimer's Disease
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 6 Jan 2025
Ocutrx Debuts DigiLoupes(TM) Headset with Advanced AR/XR and Pancake Lens Technology for the First Time in the U.S.
Devices Surgery Product Launch
 HSMN NewsFeed - 3 Jan 2025
The Mayo Clinic, the leading US hospital, will test Nevisense in Pilot
Devices Dermatology
 HSMN NewsFeed - 2 Jan 2025
Movano Health Welcomes Dr. Shaheen Wirk to its Board of Directors
Devices Monitoring Personnel
 HSMN NewsFeed - 31 Dec 2024
Kazia Therapeutics Provides Update on Paxalisib Regulatory Pathway Following Type C Meeting with FDA
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 30 Dec 2024
Halozyme Announces FDA Approval of Bristol Myers Squibb's Opdivo Qvantig(TM) with ENHANZE(R) for Subcutaneous Use in Most Previously Approved Adult Solid Tumor Opdivo(R) (nivolumab) Indications
Biopharmaceuticals Drug Delivery Oncology FDA
 HSMN NewsFeed - 20 Dec 2024
Neurocrine Biosciences Announces Commercial Availability of CRENESSITY(TM) (crinecerfont) for Children and Adults With Classic Congenital Adrenal Hyperplasia
Biopharmaceuticals Product Launch
 HSMN NewsFeed - 13 Dec 2024
Zimmer Biomet Receives FDA Clearance for OsseoFit(TM) Stemless Shoulder System for Total Shoulder Replacement
Devices Orthopaedic FDA
 HSMN NewsFeed - 12 Dec 2024
U.S. FDA Expands Indication for Impella Heart Pumps to Treat Pediatric Patients
Devices Cardiology FDA
 HSMN NewsFeed - 10 Dec 2024
PENTAX Medical Obtained US FDA 510(k) Clearance for New Models of the PENTAX Medical i20c Video Endoscope Series
Devices Gastroenterology FDA
 HSMN NewsFeed - 9 Dec 2024
AnX Robotica awarded Gastrointestinal Endoscopy Products agreement with Premier, Inc.
Devices Gastroenterology Group Purchasing
 HSMN NewsFeed - 6 Dec 2024
EQT Life Sciences Leads Series A Funding Round for Maternal Health Company Nua Surgical
Devices Surgery Venture Capital
 HSMN NewsFeed - 4 Dec 2024
Study published in the New England Journal of Medicine AI Concludes that the Sepsis ImmunoScore(TM), the First FDA-Authorized AI Tool for Sepsis, has both significant Diagnostic and Predictive Power
Diagnostics
 HSMN NewsFeed - 27 Nov 2024
PTC Therapeutics Enters into Agreement to Sell Priority Review Voucher for $150 Million
Biopharmaceuticals FDA
 HSMN NewsFeed - 25 Nov 2024
LifeSignals Receives FDA 510(k) Approval for UbiqVue(TM) 2A Multiparameter System
Devices Monitoring FDA
 HSMN NewsFeed - 22 Nov 2024
U.S. FDA Approves StemCyte Biologics License Application for REGENECYTE(TM) Cord Blood Cell Therapy Product
Biopharmaceuticals FDA
 HSMN NewsFeed - 20 Nov 2024
Medtronic Receives FDA Clearance for New InPen(TM) App, Paving the Way for its Smart MDI System Launch with Simplera(TM) CGM
Devices Monitoring FDA
 HSMN NewsFeed - 19 Nov 2024
THINK Surgical Receives FDA 510(k) Clearance to Use Freedom(R) Total Knee, Freedom Titan(R) Knee, and Freedom Primary PCK(R) System Implants with TMINI(R) Miniature Robotic System
Devices Orthopaedic FDA
 HSMN NewsFeed - 13 Nov 2024
SmartCardia Receives FDA Clearance for Outpatient Cardiac Telemetry for Its 7-Lead ECG Patch and Cloud Platform
Devices Monitoring Cardiology FDA
 HSMN NewsFeed - 12 Nov 2024
Nevro's HFX iQ(TM) Spinal Cord Stimulation with AI Technology Receives CE Mark Certification in Europe, Increasing Product Expansion Globally
Devices Regulatory
 HSMN NewsFeed - 11 Nov 2024
Momentis Surgical Receives FDA 510(k) Clearance for Second Generation Anovo(R) Robotic Platform, Introducing Haptic Feedback and Dual-Mode Articulation
Devices Surgery FDA
 HSMN NewsFeed - 8 Nov 2024
FDA Advisory Panel Votes in Favor of IceCure's ProSense(R) Cryoablation Benefit-Risk Profile in Early-Stage Low Risk Breast Cancer
Devices Oncology FDA
 HSMN NewsFeed - 5 Nov 2024
Xeltis expands leadership team with appointment of Luc Verhees as Vice President of Clinical Business Development
Devices Personnel
 HSMN NewsFeed - 1 Nov 2024
CARsgen(R) U.S. Clinical Holds Lifted by FDA
Biopharmaceuticals FDA
 HSMN NewsFeed - 31 Oct 2024
Lipocine Announces Distribution and License Agreement with SPC Korea to Commercialize TLANDO(R) in South Korea
Biopharmaceuticals Licensing Distribution
 HSMN NewsFeed - 30 Oct 2024
Laura J. Seplavy, MS, Joins Perosphere as Executive Vice President, Marketing and External Relations
Devices Diagnostics Personnel
 HSMN NewsFeed - 30 Oct 2024
FDA Grants Orphan Drug Designation to Capsida Biotherapeutics for Potential Treatment of STXBP1 Developmental and Epileptic Encephalopathy
Biopharmaceuticals FDA
 HSMN NewsFeed - 29 Oct 2024
Protega Pharmaceuticals Receives FDA Approval for ROXYBOND(TM) (oxycodone hydrochloride) Immediate-Release 10 mg Tablet with Abuse-Deterrent Technology for Management of Pain
Biopharmaceuticals FDA
 HSMN NewsFeed - 28 Oct 2024
Zimmer Biomet to Debut New Z1(TM) Femoral Hip System and Clinical Data on G7(R) Acetabular System at 2024 AAHKS Annual Meeting
Devices Orthopaedic Product Launch
 HSMN NewsFeed - 25 Oct 2024
Lilly's EBGLYSS(TM) (lebrikizumab-lbkz) Demonstrated Meaningful Improvement in Skin Clearance and Itch Relief in the Majority of Patients with Moderate-To-Severe Atopic Dermatitis Who Discontinued Dupilumab
Biopharmaceuticals Dermatology
 HSMN NewsFeed - 24 Oct 2024
Pillar Biosciences Receives CPT(R) Code for FDA Approved oncoReveal(TM) CDx Pan-Cancer Solid tumor IVD Kit
Diagnostics Oncology Reimbursement
 HSMN NewsFeed - 24 Oct 2024
Accent Therapeutics Announces FDA Clearance of IND Application for ATX-559, a First-In-Class Oral DHX9 Inhibitor
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 17 Oct 2024
MolecuLight's Fluorescence Imaging: A Game-Changer for Bedside Biofilm Detection
Devices Wound Care
 HSMN NewsFeed - 16 Oct 2024
Bracco Diagnostics Inc. and Subtle Medical Announce FDA Clearance of AiMIFY(TM) Software for Enhanced MRI
Devices Radiology FDA
 HSMN NewsFeed - 15 Oct 2024
Accure Acne Announces New FDA Clearance for the Long-Term Treatment of Acne
Devices Dermatology FDA
 HSMN NewsFeed - 11 Oct 2024
X-Bolt Announces First U.S. Implant of Pro-X1(R) Trochanteric Nailing System
Devices Orthopaedic Product Launch
 HSMN NewsFeed - 10 Oct 2024
Johnson & Johnson MedTech Launches VOLT(TM) Plating System
Devices Orthopaedic Product Launch
 HSMN NewsFeed - 9 Oct 2024
ShiraTronics Raises $66 Million in Oversubscribed Series B Financing to Advance Pioneering Treatment for Chronic Migraine
Devices Neurology Venture Capital
 HSMN NewsFeed - 9 Oct 2024
Inspira(TM) Announces Development of New Disposable Kit with Built-In Performance Monitoring Mechanism
Devices
 HSMN NewsFeed - 8 Oct 2024
Regenity Biosciences Receives 510(k) Clearance for RejuvaKnee(TM), a Groundbreaking Regenerative Meniscus Implant Device to Redefine the Standard of Care
Devices Orthopaedic FDA
 HSMN NewsFeed - 8 Oct 2024
BTL's Emsculpt Neo Secures FDA Clearance for Treating Medical Diseases and Conditions, Expanding Market Reach
Devices FDA
 HSMN NewsFeed - 7 Oct 2024
ALK Announces U.S. FDA Approval of New AccuTest(TM) Allergy Skin Testing Devices for Optimized Allergy Testing and Diagnosis
Diagnostics FDA
 HSMN NewsFeed - 4 Oct 2024
Voluntary Recall Notifying Medtronic Insulin Pump Users of Potential Risks of Shortened Pump Battery Life
Devices Drug Delivery Product Recall
 HSMN NewsFeed - 3 Oct 2024
Avidity Biosciences Announces FDA Removed Partial Clinical Hold on Delpacibart Etedesiran (del-desiran/AOC 1001)
Biopharmaceuticals FDA
 HSMN NewsFeed - 2 Oct 2024
Kedrion and Biotest complete long-term Exclusive Distribution Agreement for Yimmugo(R) in the US
Biopharmaceuticals Distribution
 HSMN NewsFeed - 1 Oct 2024
Auto Depth Digital Wound Measurement Now Available on MolecuLightDX
Devices Wound Care Product Launch
 HSMN NewsFeed - 26 Sep 2024
FDA Grants Fast Track Designation to PTC518 Huntington's Disease Program
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 25 Sep 2024
Heron Therapeutics Announces FDA Approval of the Prior Approval Supplement Application for ZYNRELEF(R) Vial Access Needle ("VAN")
Devices Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 24 Sep 2024
B. Braun Medical Receives FDA Clearance for Introcan Safety(R) 2 Deep Access IV Catheter
Devices FDA
 HSMN NewsFeed - 23 Sep 2024
UCB Announces U.S. FDA Approvals for BIMZELX(R) (bimekizumab-bkzx) for the Treatment of Psoriatic Arthritis, Non-Radiographic Axial Spondyloarthritis, and Ankylosing Spondylitis
Biopharmaceuticals FDA
 HSMN NewsFeed - 19 Sep 2024
FDA Declines to Approve Vanda's Marketing Application for Tradipitant in Gastroparesis
Biopharmaceuticals FDA
 HSMN NewsFeed - 18 Sep 2024
Accord BioPharma, Inc. Announces U.S. Food & Drug Administration Approval of 420mg Strength of HERCESSI(TM) (trastuzumab-strf), a biosimilar to Herceptin(R) (trastuzumab), for the Treatment of Several Forms of HER2-Overexpressing Cancer
Biopharmaceuticals Generics Oncology FDA
 HSMN NewsFeed - 17 Sep 2024
Boston Scientific Receives FDA Approval for Expanded Indication of INGEVITY(TM)+ Pacing Leads to Include Conduction System Pacing of the Left Bundle Branch Area
Devices Cardiology FDA
 HSMN NewsFeed - 12 Sep 2024
Inflammatix Secures $57 Million to Advance Novel Diagnostic for Patients with Suspected Infections or Sepsis
Diagnostics Venture Capital
 HSMN NewsFeed - 10 Sep 2024
Solventum Launches All-In-One, Extended-Wear Wound Dressing for V.A.C.(R) Therapy
Devices Wound Care Product Launch
 HSMN NewsFeed - 3 Sep 2024
Forward Therapeutics Welcomes Ulrich Thienel, M.D., Ph.D. as Chief Medical Officer
Biopharmaceuticals Personnel
 HSMN NewsFeed - 29 Aug 2024
Expanse Medical Welcomes Jeff Hopkins as CEO and Board Member of its Spin-Off, FlowPhysix
Devices Interventional Personnel
 HSMN NewsFeed - 28 Aug 2024
Neuros Medical Receives FDA Approval for the Altius(R) Direct Electrical Nerve Stimulation System
Devices FDA
 HSMN NewsFeed - 20 Aug 2024
Pathalys Pharma Secures $105 Million Series B Financing
Biopharmaceuticals Venture Capital
 HSMN NewsFeed - 20 Aug 2024
RYBREVANT(R) (amivantamab-vmjw) Plus LAZCLUZE(TM) (lazertinib) Approved in the U.S. as a First-line Chemotherapy-free Treatment for Patients with EGFR-mutated Advanced Lung Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 13 Aug 2024
Surgical Planning Associates Receives FDA Clearance for New HipInsight System(R) 2.0 Mixed-Reality System for Hip Arthroplasty
Devices Orthopaedic FDA
 HSMN NewsFeed - 9 Aug 2024
FDA Approves First Nasal Spray for Treatment of Anaphylaxis
Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 8 Aug 2024
Sobi and Apellis announce positive topline results from phase 3 VALIANT study of pegcetacoplan in C3G and primary IC-MPGN
Biopharmaceuticals
 HSMN NewsFeed - 29 Jul 2024
Syndax Announces PDUFA Action Date Extension for Revumenib NDA for Relapsed or Refractory KMT2Ar Acute Leukemia
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 25 Jul 2024
BD, Quest Diagnostics Join Forces to Develop Companion Diagnostics for Cancer, Other Diseases
Diagnostics Oncology
 HSMN NewsFeed - 23 Jul 2024
Magenta Medical Closes $105M Financing Led by Novo Holdings
Devices Interventional Cardiology Venture Capital
 HSMN NewsFeed - 22 Jul 2024
Latigo Biotherapeutics Appoints Nima Farzan as Chief Executive Officer, Positioning Company for Rapid Growth
Biopharmaceuticals Personnel
 HSMN NewsFeed - 11 Jul 2024
Akebia Therapeutics Provides Update on Continued Momentum of Commercial Launch of Vafseo(R) (vadadustat) Tablets
Biopharmaceuticals
 HSMN NewsFeed - 5 Jul 2024
Biostar Pharma Announces FDA Clearance of the IND Application for a Phase 2 Study of Utidelone Injection (UTD1) in HER2- Breast Cancer Brain Metastasis
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 2 Jul 2024
Alafair Biosciences Awarded Synthetic Implantable Products Agreement with Premier, Inc. for VersaWrap(R) Hydrogel Sheet
Devices Surgery Group Purchasing
 HSMN NewsFeed - 27 Jun 2024
VenoStent Completes $20 Million Series A with $4 Million Investment from Norwest Venture Partners
Devices Venture Capital
 HSMN NewsFeed - 26 Jun 2024
BrainStorm Cell Therapeutics Reaches Alignment with FDA on CMC Aspects of Phase 3b NurOwn(R) Clinical Trial
Regenerative Medicine Neurology FDA
 HSMN NewsFeed - 24 Jun 2024
Harmony Biosciences Receives U.S. Food And Drug Administration Approval For Wakix(R) (Pitolisant) In Pediatric Patients With Narcolepsy
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 21 Jun 2024
FDA Authorizes Marketing of Four Menthol-Flavored E-Cigarette Products After Extensive Scientific Review
Drug Delivery FDA
 HSMN NewsFeed - 20 Jun 2024
BrainStorm Cell Therapeutics Announces Appointment of Haro Hartounian Ph.D. as Chief Operating Officer
Regenerative Medicine Personnel
 HSMN NewsFeed - 19 Jun 2024
European Commission grants Sobi(R) Marketing Authorisation for ALTUVOCT(TM) for treatment of haemophilia A
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 18 Jun 2024
Roche receives FDA clearance on its digital pathology solution for diagnostic use
Devices Diagnostics FDA
 HSMN NewsFeed - 14 Jun 2024
TALVEY(R) (talquetamab-tgvs) Demonstrates Highly Durable, Longer-Term Responses in Patients with Relapsed or Refractory Multiple Myeloma
Biopharmaceuticals Oncology
 HSMN NewsFeed - 13 Jun 2024
Xeltis receives IDE approval from FDA for initiation of US pivotal trial for aXess(TM), its restorative vascular access conduit
Devices FDA
 HSMN NewsFeed - 11 Jun 2024
Amber Implants Completes Enrollment of First-In-Human Clinical Trial of its VCFix(R) Spinal System
Devices Orthopaedic Neurosurgery
 HSMN NewsFeed - 10 Jun 2024
Abbott Receives U.S. FDA Clearance for Two New Over-the-Counter Continuous Glucose Monitoring Systems
Devices Endocrinology Monitoring FDA
 HSMN NewsFeed - 7 Jun 2024
DePuy Synthes Receives 510(k) FDA Clearance of the VELYS(TM) Robotic-Assisted Solution for Use in Unicompartmental Knee Arthroplasty Procedures
Devices Orthopaedic FDA
 HSMN NewsFeed - 5 Jun 2024
Moon Surgical receives second FDA clearance, covering its commercial Maestro(TM) Robotic Surgery System
Devices Surgery FDA
 HSMN NewsFeed - 4 Jun 2024
Zeto obtains FDA 510(k) clearance for its groundbreaking next-generation EEG brain monitoring product, ONE.
Devices Neurology Monitoring FDA
 HSMN NewsFeed - 30 May 2024
US FDA Awards Supplemental Orphan Drug Designation to Survaxm to Now Include Treatment of Malignant Glioma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 29 May 2024
Beckman Coulter Secures FDA Clearance for Heart Failure Assay on DxI 9000 Immunoassay Analyzer
Devices Diagnostics Cardiology FDA
 HSMN NewsFeed - 28 May 2024
Terumo Cardiovascular Announces 510(K) Clearance for the CDI OneView(TM) Monitoring System
Devices Monitoring FDA
 HSMN NewsFeed - 21 May 2024
Biocon Biologics Obtains U.S. FDA Approval for Biosimilar Aflibercept for Yesafili(TM). Enters U.S. Ophthalmology Market
Biopharmaceuticals Generics Ophthalmology FDA
 HSMN NewsFeed - 17 May 2024
Implicity Earns FDA Clearance for New Heart Failure Prediction Algorithm
Devices Monitoring Cardiology FDA
 HSMN NewsFeed - 16 May 2024
FX Shoulder Solutions, Inc. Receives FDA 510k Clearance for Full-Wedge Augmented Glenoid Baseplates
Devices Orthopaedic FDA
 HSMN NewsFeed - 14 May 2024
Brixton Biosciences Announces $33M in Series B Funding to Advance Novel Technology for the Treatment of Pain
Biopharmaceuticals Venture Capital
 HSMN NewsFeed - 14 May 2024
Nanoscope Therapeutics Appoints Khandan Baradaran as Senior Vice President of Regulatory and Quality
Regenerative Medicine Ophthalmology Personnel
 HSMN NewsFeed - 13 May 2024
CereVasc Announces $70 Million Series B Financing to Advance its Novel eShunt(R) System for the Treatment of Normal Pressure Hydrocephalus
Devices Neurosurgery Venture Capital
 HSMN NewsFeed - 13 May 2024
Laborie Unveils Positive Study Results for Optilume(R) BPH Catheter System
Devices Urology
 HSMN NewsFeed - 9 May 2024
OrthoXel Receives FDA 510(k) Clearance for their Vertex Hip Fracture Nail (HFN)
Devices Orthopaedic FDA
 HSMN NewsFeed - 8 May 2024
4C Medical's AltaValve System Secures Dual FDA Breakthrough Device Designations, Expediting Patient Access to Advanced Mitral Valve Therapies
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 6 May 2024
Scientia Vascular Announces FDA approvals for New Line of Microfabricated Neurovascular Catheters
Devices Interventional Neurology FDA
 HSMN NewsFeed - 3 May 2024
Leading Academic Neurosurgeons Describe New NICO Myriad SPECTRA(TM) System as a 'Game-Changing Advancement' in Surgical Removal of High-Grade Glioma Brain Tumors
Devices Neurosurgery Oncology
 HSMN NewsFeed - 1 May 2024
MagVenture Announces Collaboration with Magnus Medical to Bring the SAINT(R) Neuromodulation System to Market
Devices Neurology
 HSMN NewsFeed - 29 Apr 2024
Labcorp Receives FDA Approval for First Companion Diagnostic for Use with Pfizer's Newly Approved Gene Therapy to Treat Patients with Hemophilia B
Biopharmaceuticals Diagnostics FDA
 HSMN NewsFeed - 26 Apr 2024
Sobi(R) Receives Positive CHMP Opinion Recommending Approval of Efanesoctocog Alfa for Once-Weekly Treatment of Haemophilia A
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 25 Apr 2024
Provisio Medical Announces FDA Clearance of the Provisio SLT IVUS(TM) System
Devices FDA
 HSMN NewsFeed - 24 Apr 2024
Valcare Medical, Inc. Announces Corporate Restructuring and Appointment of New CEO
Devices Interventional Cardiology Personnel
 HSMN NewsFeed - 19 Apr 2024
Legacy Medical Consultants Announces Reeva FT(TM), a Full-Thickness Allograft for Wound Covering and Protection During Treatment
Devices Wound Care Product Launch Reimbursement
 HSMN NewsFeed - 16 Apr 2024
Xstim, Inc. Receives FDA Approval for Xstim(TM) Spine Fusion Stimulator
Devices Neurosurgery Orthopaedic FDA
 HSMN NewsFeed - 15 Apr 2024
Labcorp Announces First-of-Its-Kind Test for Early Indication of Neurodegenerative Diseases and Brain Injuries Using a Blood Draw
Diagnostics Neurology Product Launch
 HSMN NewsFeed - 8 Apr 2024
Mitsubishi Tanabe Pharma America Receives U.S. Food and Drug Administration Orphan Drug Exclusivity for RADICAVA ORS(R) (edaravone)
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 5 Apr 2024
Labcorp Launches Labcorp(R) Plasma Detect(TM) Extending Leadership into Molecular Residual Disease (MRD) Clinical Research
Diagnostics Oncology Product Launch
 HSMN NewsFeed - 3 Apr 2024
Kintara Therapeutics and TuHURA Biosciences Enter into Definitive Merger Agreement
Biopharmaceuticals Oncology Mergers & Acquisitions
 HSMN NewsFeed - 2 Apr 2024
NeoImmuneTech Appoints Dr. Luke Oh, Ph.D. as New Chief Executive Officer
Biopharmaceuticals Oncology Personnel
 HSMN NewsFeed - 2 Apr 2024
NEOS Cranial LOOP(TM) Receives FDA Clearance for CustomizedBone(TM) Use
Devices Neurosurgery FDA
 HSMN NewsFeed - 29 Mar 2024
RIVANNA(R) Appoints Craig Loomis as Senior Director of Product Management
Devices Radiology Personnel
 HSMN NewsFeed - 28 Mar 2024
Nested Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for NST-628, a Novel Pan-RAF/MEK Molecular Glue
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 27 Mar 2024
Medtronic Announces FDA Approval of Newest-Generation Evolut TAVR System for Treatment of Symptomatic Severe Aortic Stenosis
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 22 Mar 2024
Astellas Receives Positive CHMP Opinion for XTANDI(TM) in Additional Recurrent Early Prostate Cancer Treatment Setting
Biopharmaceuticals Oncology Regulatory
 HSMN NewsFeed - 21 Mar 2024
Renibus Announces Leadership Transition
Biopharmaceuticals Personnel
 HSMN NewsFeed - 15 Mar 2024
Delcath Systems Announces $7 Million Private Placement
Biopharmaceuticals Drug Delivery Oncology Venture Capital
 HSMN NewsFeed - 14 Mar 2024
Celluma Light Therapy Introduces the RESTORE Hair Therapy System
Biopharmaceuticals Devices Product Launch
 HSMN NewsFeed - 13 Mar 2024
Ventris Medical Receives 510(k) Additional Clearance for Amplify(R) Standalone Bone Graft Putty
Devices FDA
 HSMN NewsFeed - 11 Mar 2024
FDA Grants Orphan Drug and Pediatric Exclusivities for CRESEMBA(R) (isavuconazonium sulfate) for Invasive Aspergillosis and Invasive Mucormycosis in Children
Biopharmaceuticals FDA
 HSMN NewsFeed - 8 Mar 2024
U.S. Food and Drug Administration to Convene Advisory Committee Meeting to Discuss the TRAILBLAZER-ALZ 2 Study of Donanemab
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 5 Mar 2024
ADI Announces U.S. FDA 510(k) Clearance and the Commercial Launch of Sensinel by Analog Devices(TM) Cardiopulmonary Management (CPM) System
Devices Cardiology Monitoring FDA
 HSMN NewsFeed - 5 Mar 2024
Haemonetics Announces Definitive Agreement to Acquire Attune Medical
Devices Mergers & Acquisitions
 HSMN NewsFeed - 1 Mar 2024
Mallinckrodt Announces U.S. FDA Approval of Supplemental New Drug Application for Acthar(R) Gel (repository corticotropin injection) Single-Dose Pre-filled SelfJect(TM) Injector
Devices Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 1 Mar 2024
Boston Scientific Receives FDA Approval for the AGENT(TM) Drug-Coated Balloon
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 29 Feb 2024
Spatz Medical Marks Milestone: Spatz3 Adjustable Gastric Balloon Launches in the U.S. in March 2024
Devices Gastroenterology Product Launch
 HSMN NewsFeed - 28 Feb 2024
Baird Medical Expands Presence in the United States
Devices Oncology Personnel
 HSMN NewsFeed - 27 Feb 2024
Nuvalent Receives U.S. FDA Breakthrough Therapy Designation for NVL-520
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 26 Feb 2024
Laplace Interventional Inc. Announces Successful First in Human Procedure in Early Feasibility Study of its Transcatheter Tricuspid Valve Replacement Device
Devices Interventional Cardiology
 HSMN NewsFeed - 23 Feb 2024
BrainStorm Cell Therapeutics Submits Special Protocol Assessment (SPA) Request to FDA for Phase 3b Trial of NurOwn(R) in ALS
Regenerative Medicine Neurology FDA
 HSMN NewsFeed - 22 Feb 2024
Zimmer Biomet Receives FDA Clearance for ROSA(R) Shoulder System - the World's First Robotic Assistant for Shoulder Replacement Surgery
Devices Orthopaedic FDA
 HSMN NewsFeed - 22 Feb 2024
Lancet Digital Health Study Confirms MAGENTIQ-COLO(TM) AI-aided Colonoscopy Technology Improves Adenoma Detection Rates
Devices Gastroenterology
 HSMN NewsFeed - 21 Feb 2024
Sira Medical Wins FDA Clearance for Augmented Reality Preoperative Surgical Planning Software
Devices Surgery FDA
 HSMN NewsFeed - 20 Feb 2024
Avidity Biosciences Receives FDA Rare Pediatric Disease Designation for AOC 1044 for Treatment of Duchenne Muscular Dystrophy in People with Mutations Amenable to Exon 44 Skipping
Biopharmaceuticals FDA
 HSMN NewsFeed - 14 Feb 2024
Efemoral Medical Granted Breakthrough Device Designation
Devices Interventional FDA
 HSMN NewsFeed - 13 Feb 2024
ProfoundBio Raises $112 Million in Oversubscribed Series B Equity Financing to Advance its Clinical-Stage Antibody-Drug Conjugate (ADC) Pipeline
Biopharmaceuticals Oncology Venture Capital
 HSMN NewsFeed - 12 Feb 2024
AbbVie Completes Acquisition of ImmunoGen
Biopharmaceuticals Oncology Mergers & Acquisitions
 HSMN NewsFeed - 7 Feb 2024
Innova Vascular Announces Successful Early Commercial Use of Laguna Thrombectomy System(TM) in Patients
Devices Interventional
 HSMN NewsFeed - 6 Feb 2024
Zynex Receives FDA Clearance for its Next Generation NMES Device
Devices FDA
 HSMN NewsFeed - 6 Feb 2024
FDA Clears Groundbreaking Corplex P(TM): The First Human Umbilical Cord-Derived Medical Device
Devices Wound Care FDA
 HSMN NewsFeed - 31 Jan 2024
Labcorp Launches New Test for Risk Assessment and Prognosis of Severe Preeclampsia in Pregnant Women
Diagnostics Product Launch
 HSMN NewsFeed - 30 Jan 2024
BD, Techcyte Announce Strategic Collaboration to Offer AI-Based Digital Cervical Cytology System for Pap Testing
Diagnostics Oncology
 HSMN NewsFeed - 24 Jan 2024
ZWI Therapeutics, Inc. Announces a Series A Financing, Two Accomplished Biopharmaceutical CEOs Join the Board of Directors, and Appointment of Chief Executive Officer
Biopharmaceuticals Personnel Venture Capital
 HSMN NewsFeed - 23 Jan 2024
FDA Grants Breakthrough Device Designation to Amadix´s preventive screening blood test for Colorectal Cancer
Diagnostics Oncology FDA
 HSMN NewsFeed - 19 Jan 2024
Kyverna Therapeutics Granted FDA Fast Track Designation for KYV-101 in the Treatment of Patients With Refractory Progressive Multiple Sclerosis
Regenerative Medicine Neurology FDA
 HSMN NewsFeed - 18 Jan 2024
Cepheid Receives Expanded FDA Clearance with CLIA Waiver for Xpert(R) Xpress MVP
Diagnostics FDA
 HSMN NewsFeed - 16 Jan 2024
Orlucent Demonstrates Accurate, Non-Invasive Detection in vivo of Melanoma-Related Activity Using First-in-Kind Handheld Mole Imaging System
Devices Dermatology
 HSMN NewsFeed - 15 Jan 2024
NeoImmuneTech Welcomes a New President for its Development and Business
Biopharmaceuticals Oncology Personnel
 HSMN NewsFeed - 12 Jan 2024
Darmiyan Receives FDA Approval for BrainSee, the First Prognostic Test for Predicting Likelihood of Progression to Alzheimer's Dementia
Diagnostics Neurology FDA
 HSMN NewsFeed - 11 Jan 2024
Zeta Surgical's Mixed Reality Navigation System Receives FDA Special 510(k) Clearance for Expanded Functionality
Devices Neurosurgery FDA
 HSMN NewsFeed - 10 Jan 2024
Providence Medical Technology Announces FDA Clearance of CAVUX(R) FFS-LX Lumbar Facet Fixation System for 1- and 2-Level Lumbar Spinal Fusion
Devices Neurosurgery Orthopaedic FDA
 HSMN NewsFeed - 9 Jan 2024
TORL BioTherapeutics Announces Appointment of Mark J. Alles as Chairman and Chief Executive Officer; Highlights Significant Progress of its Oncology Clinical Programs
Biopharmaceuticals Oncology Personnel
 HSMN NewsFeed - 8 Jan 2024
Medtronic Diabetes announces world's first approval for MiniMed(TM) 780G System with Simplera Sync(TM) disposable, all-in-one sensor
Devices Monitoring Regulatory
 HSMN NewsFeed - 3 Jan 2024
Vasa Therapeutics Announces Closing of Seed Financing to Advance Novel Therapies for Diseases of Cardiovascular Aging
Biopharmaceuticals Cardiology Venture Capital
 HSMN NewsFeed - 2 Jan 2024
Pulnovo Medical Announces PADN Receives FDA HUD Designation and US CMS Medicare Coverage Code and NMPA Approval
Devices Regulatory FDA Reimbursement
 HSMN NewsFeed - 26 Dec 2023
Amgen Provides Regulatory Update on Status of Lumakras(R) (Sotorasib)
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 20 Dec 2023
FeelTect secures €1.5 million investment for connected wound treatment technology
Devices Wound Care Monitoring Venture Capital
 HSMN NewsFeed - 18 Dec 2023
NeuExcell's AAV Gene Therapy for Malignant Glioma Granted Orphan Drug Designation by FDA
Regenerative Medicine Neurosurgery Oncology FDA
 HSMN NewsFeed - 15 Dec 2023
CymaBay Submits New Drug Application to FDA for Seladelpar for the Treatment of Primary Biliary Cholangitis
Biopharmaceuticals FDA
 HSMN NewsFeed - 13 Dec 2023
Kyverna Therapeutics Granted FDA Fast Track Designation for KYV-101 in the Treatment of Patients With Refractory Myasthenia Gravis
Biopharmaceuticals FDA
 HSMN NewsFeed - 13 Dec 2023
Triveni Bio Welcomes Jeff Albers and Allison Luo to its Board of Directors
Biopharmaceuticals Personnel
 HSMN NewsFeed - 7 Dec 2023
BD Receives FDA 510(k) Clearance for Potentially Transformative Fingertip Blood Collection Device
Devices Diagnostics FDA
 HSMN NewsFeed - 6 Dec 2023
NSite Medical Announces FDA Clearance for Groundbreaking AI-Based Scoliosis Scanning App
Devices FDA
 HSMN NewsFeed - 5 Dec 2023
ABK Biomedical Announces That its Eye90 Microspheres(R) Device Has Been Granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA)
Devices Oncology FDA
 HSMN NewsFeed - 28 Nov 2023
Inflammatix Receives Breakthrough Device Designation from FDA for TriVerity(TM) Acute Infection and Sepsis Test System
Diagnostics FDA
 HSMN NewsFeed - 27 Nov 2023
RTI Surgical Inc. Receives FDA IDE Approval for the Clinical Investigation of Cortiva(R) Allograft Dermis in Breast Reconstruction
Devices Surgery FDA
 HSMN NewsFeed - 24 Nov 2023
Novartis Issues Voluntary US Nationwide Recall of Two Lots of Sandimmune(R) Oral Solution (cyclosporine oral solution, USP), 100 mg/mL due to Crystallization
Biopharmaceuticals Product Recall
 HSMN NewsFeed - 22 Nov 2023
Vaccine Partner Valneva receives FDA approval for the World's first chikungunya vaccine using Albumedix' Recombumin(R)
Biopharmaceuticals FDA
 HSMN NewsFeed - 20 Nov 2023
FDA Grants Orphan Drug Designation to NeoImmuneTech's NT-I7 for the Treatment of Acute Radiation Syndrome
Biopharmaceuticals FDA
 HSMN NewsFeed - 16 Nov 2023
Ad Astra Diagnostics receives 510(k) clearance of QScout(TM) hematology analyzer, the first to report measures of infection and severity at point-of-care
Diagnostics FDA
 HSMN NewsFeed - 14 Nov 2023
FDA Clears Sirius Pintuition(R) for Long-term and Soft Tissue Implantation
Devices Oncology Surgery FDA
 HSMN NewsFeed - 10 Nov 2023
Mirati Therapeutics Receives Positive Opinion from CHMP for KRAZATI (adagrasib) as a Targeted Treatment Option for Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) with a KRASG12C Mutation Following a Re-Examination Procedure
Biopharmaceuticals Oncology Regulatory
 HSMN NewsFeed - 10 Nov 2023
EU Approval of AAV5 DetectCDx(TM) Provides Access to Companion Diagnostic for Hemophilia A Gene Therapy
Diagnostics Regulatory
 HSMN NewsFeed - 8 Nov 2023
Recor Medical and Otsuka Medical Devices Announce First FDA-Approved Renal Denervation System for the Treatment of Hypertension
Devices Cardiology FDA
 HSMN NewsFeed - 7 Nov 2023
Johnson & Johnson MedTech Provides Details and Timeline for General Surgery Robot
Devices Surgery FDA
 HSMN NewsFeed - 2 Nov 2023
BD Advances "One-Stick Hospital Stay" Vision with Launch of Next-Generation Needle-Free Blood Draw Technology
Devices FDA Product Launch
 HSMN NewsFeed - 31 Oct 2023
FDA Approves Novartis Cosentyx(R) as the First New Biologic Treatment Option for Hidradenitis Suppurativa Patients in Nearly a Decade
Biopharmaceuticals FDA
 HSMN NewsFeed - 27 Oct 2023
Laborie Medical Technologies Acquires Urotronic
Devices Urology Mergers & Acquisitions
 HSMN NewsFeed - 26 Oct 2023
Centinel Spine(R) PMA Application for First-of-its-Kind 2-Level prodisc(R) C Vivo and prodisc C SK Match-the-Disc(TM) Cervical Total Disc Replacement System Filed and Proceeding with Substantive Review
Devices Neurosurgery Orthopaedic FDA
 HSMN NewsFeed - 24 Oct 2023
BrainStorm Cell Therapeutics Announces Strategic Realignment Prioritizing NurOwn(R) for the Treatment of ALS
Regenerative Medicine Neurology
 HSMN NewsFeed - 23 Oct 2023
Medtronic receives FDA approval for extravascular defibrillator to treat abnormal heart rhythms, sudden cardiac arrest
Devices Cardiology FDA
 HSMN NewsFeed - 20 Oct 2023
Groundbreaking New Silk Surgical Dressing, SYLKE(TM), Launches to Prevent Skin Injuries and Infections, Improving Scarring Outcomes
Devices Surgery Wound Care Product Launch
 HSMN NewsFeed - 18 Oct 2023
BrainStorm Cell Therapeutics to Meet with US FDA to Discuss Development Plan for NurOwn as a Treatment of ALS
Regenerative Medicine Neurology
 HSMN NewsFeed - 11 Oct 2023
Labcorp Launches New Test to Accelerate Path to Diagnosis of Alzheimer's Disease
Diagnostics Neurology Product Launch
 HSMN NewsFeed - 9 Oct 2023
Endotronix Receives IDE Approval for the Market Expanding PROACTIVE-HF 2 Clinical Trial
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 4 Oct 2023
U.S. FDA Grants Lipogems(R) Second IDE Approval for a Clinical Trial on the Treatment for Knee OA
Devices Orthopaedic FDA
 HSMN NewsFeed - 2 Oct 2023
MedAlliance Acquired by Cordis for up to USD 1.135 Billion
Devices Interventional Cardiology Mergers & Acquisitions
 HSMN NewsFeed - 28 Sep 2023
2,500 Procedures Completed in U.S. with Centinel Spine's prodisc(R) C Vivo and prodisc C SK Cervical Total Disc Replacement System, Less than One Year After Limited Launch
Devices Neurosurgery Orthopaedic
 HSMN NewsFeed - 27 Sep 2023
Implicity Expands Senior Leadership Team with New U.S. Chief Commercial Officer
Devices Cardiology Monitoring Personnel
 HSMN NewsFeed - 26 Sep 2023
Abyrx Receives FDA Clearance for MONTAGE(R) Settable Bone Putty for Use in Cardiothoracic Surgery
Devices Surgery FDA
 HSMN NewsFeed - 21 Sep 2023
Tyber Medical Gains FDA and MDR Clearance for its Implantable K-Wires and Steinmann Pins in Stainless Steel and Titanium Alloy
Devices Orthopaedic FDA
 HSMN NewsFeed - 21 Sep 2023
Medtronic Diabetes announces CE Mark for new Simplera(TM) CGM with disposable all-in-one design
Devices Endocrinology Regulatory
 HSMN NewsFeed - 20 Sep 2023
VerImmune Inc. announces over $3M Additional Funding
Biopharmaceuticals Oncology Venture Capital
 HSMN NewsFeed - 20 Sep 2023
Day Zero Diagnostics Announces Completion of $16M Financing Round
Diagnostics Venture Capital
 HSMN NewsFeed - 20 Sep 2023
IceCure Medical Receives FDA Response to De Novo Classification Request for Breast Cancer
Devices FDA
 HSMN NewsFeed - 18 Sep 2023
Field Medical, Inc. Announces Oversubscribed Seed Round to Advance Next-Generation Cardiac Ablation Technology
Devices Interventional Cardiology Venture Capital
 HSMN NewsFeed - 15 Sep 2023
SmartCardia Receives FDA Clearance for its 14-Day 7-Lead ECG Real-Time Patch and Cloud Platform
Devices Cardiology Monitoring FDA
 HSMN NewsFeed - 14 Sep 2023
MedAlliance Announces Enrollment of over 1,660 Patients in Landmark SELUTION DeNovo Study
Devices Interventional Cardiology
 HSMN NewsFeed - 12 Sep 2023
Protalix BioTherapeutics Appoints Eliot Richard Forster, Ph.D. as Chairman of its Board of Directors
Biopharmaceuticals Personnel
 HSMN NewsFeed - 11 Sep 2023
OnPoint Surgical Receives 510(k) Clearance for the OnPoint Augmented Reality Spine System
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 8 Sep 2023
Citius Pharmaceuticals, Inc. Receives Regulatory Guidance from the U.S. Food and Drug Administration (FDA) regarding the Planned Resubmission of the BLA for LYMPHIR(TM)
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 7 Sep 2023
Sharps Terminator Launches Innovative Device to Reduce Sharps Medical Plastic Waste by 93%
Devices Product Launch
 HSMN NewsFeed - 7 Sep 2023
enGene Appoints Richard Bryce, MBChB, MRCGP, MFPM, as Chief Medical Officer
Biopharmaceuticals Personnel
 HSMN NewsFeed - 5 Sep 2023
First Patient with NyokAssist(TM) Interventional Ventricular Assist Device: Dr. Junbo Ge's team successfully completed the first high-risk PCI treatment supported by the new generation of interventional VAD
Devices Interventional Cardiology
 HSMN NewsFeed - 31 Aug 2023
Mallinckrodt Receives U.S. FDA Approval for Lisdexamfetamine Dimesylate Capsules and Launches Product Used to Treat Attention-Deficit/Hyperactivity Disorder (ADHD)
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 28 Aug 2023
IceCure Medical Takes Next Major Initiative as it Prepares to Accelerate the Commercialization of ProSense in U.S. and Canada: Appoints VP of Sales, North America
Devices Personnel
 HSMN NewsFeed - 23 Aug 2023
Fresenius Medical Care Announces FDA Clearance of Versi(R)HD with GuideMe Software
Devices FDA
 HSMN NewsFeed - 22 Aug 2023
Levita(R) Magnetics Wins FDA Clearance for Pioneering MARS(TM) System
Devices Surgery FDA
 HSMN NewsFeed - 21 Aug 2023
magAssist's NyokAssist(TM) granted Designation by the FDA as a Breakthrough Device
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 18 Aug 2023
FDA grants priority review for full approval of TARPEYO for the treatment of IgA Nephropathy
Biopharmaceuticals FDA
 HSMN NewsFeed - 16 Aug 2023
VintaBio Names Jennifer Kingsley Chief Commercial Officer
Biopharmaceuticals Personnel
 HSMN NewsFeed - 11 Aug 2023
Zumutor Biologics Inc Announces FDA Clearance of IND Application of ZM008, a Novel Monoclonal Antibody Drug Against Multiple Solid Cancers
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 10 Aug 2023
Baird Medical Submits Disposable Microwave Ablation Needle and MWA System Application to U.S. FDA for Treatment of Soft Tissue Microwave Ablation
Devices FDA
 HSMN NewsFeed - 8 Aug 2023
Nyra Medical names Lori Chmura as Chief Executive Officer
Devices Interventional Cardiology Personnel
 HSMN NewsFeed - 7 Aug 2023
Ligandal Inc. Appoints Tushar Nuwal as Chief Operating Officer and Chief Business Officer
Biopharmaceuticals Personnel
 HSMN NewsFeed - 7 Aug 2023
NRx Pharmaceuticals Announces the Licensure of a US Patent to Support Use of NRX-101(TM) for Chronic Pain
Biopharmaceuticals Licensing
 HSMN NewsFeed - 4 Aug 2023
Biosense Webster Receives FDA Approval for Multiple Atrial Fibrillation Ablation Products to be Used in a Workflow Without Fluoroscopy
Devices Cardiology FDA
 HSMN NewsFeed - 1 Aug 2023
BD Receives 510(k) Clearance for COVID-19, Influenza A/B, RSV Molecular Combination Test
Diagnostics FDA
 HSMN NewsFeed - 31 Jul 2023
Viatris Announces Launch of Breyna(TM) (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol, the First FDA-Approved Generic Version of Symbicort(R) for People with Asthma and Chronic Obstructive Pulmonary Disease, in Partnership with Kindeva
Biopharmaceuticals Generics Product Launch
 HSMN NewsFeed - 27 Jul 2023
FDA Grants Clearance for UltraSight's AI-Powered Cardiac Ultrasound Technology
Devices Cardiology Radiology FDA
 HSMN NewsFeed - 25 Jul 2023
Beckman Coulter Receives FDA Clearance for DxC 500 AU Chemistry Analyzer, Expanding Portfolio with Proven Six Sigma Performance
Diagnostics FDA
 HSMN NewsFeed - 24 Jul 2023
BD CEO Tom Polen Addresses FDA 510(k) Clearance of BD Alaris(TM) Infusion System
Devices FDA
 HSMN NewsFeed - 21 Jul 2023
Hubly Surgical Raises $3 Million in Oversubscribed Funding Round Following FDA Clearance
Devices Neurosurgery Venture Capital
 HSMN NewsFeed - 20 Jul 2023
Boehringer Ingelheim Receives FDA Approval for NexGard(R) PLUS (afoxolaner, moxidectin and pyrantel chewable tablets): A Beef-Flavored Soft Chew That Protects Dogs from Internal and External Parasites
Biopharmaceuticals Veterinary FDA
 HSMN NewsFeed - 20 Jul 2023
MediView Receives FDA 510(k) Clearance for XR90 Augmented Reality-Based Visualization and Navigation Platform
Devices Surgery FDA
 HSMN NewsFeed - 19 Jul 2023
GT Medical Technologies Highlights Glioblastoma (GBM) Awareness Day July 19 and Ongoing GammaTile(R) Therapy Clinical Studies
Devices Oncology
 HSMN NewsFeed - 18 Jul 2023
Renibus Therapeutics Announces $47 Million Financing to Advance Lead Program RBT-1 Through Pivotal Phase 3 Trial
Biopharmaceuticals Venture Capital
 HSMN NewsFeed - 17 Jul 2023
Getinge recieves US FDA 510(k) clearance for Servo-air(R) Lite
Devices FDA
 HSMN NewsFeed - 12 Jul 2023
BrainStorm Cell Therapeutics Appoints Bob Dagher, M.D., as Executive Vice President and Chief Development Officer
Regenerative Medicine Personnel
 HSMN NewsFeed - 5 Jul 2023
Abbott Receives FDA Approval for World's First Dual Chamber Leadless Pacemaker
Devices Cardiology FDA
 HSMN NewsFeed - 3 Jul 2023
Skyline Therapeutics Receives FDA Clearance of IND for SKG0106, a Novel Intravitreally Delivered AAV Gene Therapy Candidate for Neovascular Age-related Macular Degeneration
Regenerative Medicine Ophthalmology FDA
 HSMN NewsFeed - 29 Jun 2023
Shane Brown Promoted to President of GT Medical Technologies, Inc.
Devices Oncology Personnel
 HSMN NewsFeed - 26 Jun 2023
MEDICAL IP Received US FDA 510(k) Clearance for DeepCatch, AI Software for Whole-Body Composition CT Quantification
Devices Radiology FDA
 HSMN NewsFeed - 21 Jun 2023
Intrinsic Therapeutics, Inc. Announces Positive Coverage Policy by Cigna Healthcare for Barricaid Bone-Anchored Annular Closure Device
Devices Neurosurgery Orthopaedic Reimbursement
 HSMN NewsFeed - 21 Jun 2023
Aethlon Medical Announces Investigation of the Hemopurifier(R) for Use in Organ Transplantation
Devices
 HSMN NewsFeed - 19 Jun 2023
Sirnaomics Advances STP705 for Squamous Cell Carcinoma In Situ into Late-Stage Clinical Development
Biopharmaceuticals Oncology
 HSMN NewsFeed - 12 Jun 2023
FDA Clears CorNeat EverPatch, World's First Non-degradable, Synthetic Tissue Substitute for Ophthalmic Surgery
Devices Ophthalmology FDA
 HSMN NewsFeed - 7 Jun 2023
Innova Vascular Earns FDA Clearance for Two New Thrombectomy Devices: Laguna Clot Retriever(TM) System and Malibu Aspiration Catheter(TM) System
Devices Interventional FDA
 HSMN NewsFeed - 6 Jun 2023
Artelon, Inc.'s FlexBand(R), FlexPatch(R), and FlexBand Plus(R) earn FDA Clearance for Ligament Reinforcement
Devices Orthopaedic Surgery FDA
 HSMN NewsFeed - 5 Jun 2023
Visgenx Appoints William Pedranti as Chief Executive Officer
Regenerative Medicine Ophthalmology Personnel
 HSMN NewsFeed - 1 Jun 2023
Penumbra Expands Computer-Aided Thrombectomy Offerings with Lightning Bolt 7 Technology Designed to Rapidly Remove Blood Clots with Modulated Aspiration
Devices Interventional Product Launch FDA
 HSMN NewsFeed - 31 May 2023
Excellent 12-Month Results from SELUTION SFA Trial Presented at JET
Devices Interventional
 HSMN NewsFeed - 30 May 2023
GT Medical Technologies Marks a Clinical Milestone: 200th Patient Enrolled in the Multicenter Observational Registry of GammaTile(R) Therapy
Devices Neurosurgery Oncology
 HSMN NewsFeed - 22 May 2023
Corvia Medical Releases Two-Year Clinical Trial Results Confirming Sustained Benefit and Safety of its Atrial Shunt in Heart Failure Patients
Devices Interventional Cardiology
 HSMN NewsFeed - 19 May 2023
Abbott Receives FDA Approval for TactiFlex(TM) Ablation Catheter for Treatment of Abnormal Heart Rhythm
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 18 May 2023
Endogenex(TM) Appoints Christopher Sorli as Chief Medical Officer
Devices Personnel
 HSMN NewsFeed - 16 May 2023
BD Gains 510(k) Clearance of Artificial Intelligence Software for MRSA Diagnostics
Diagnostics FDA
 HSMN NewsFeed - 10 May 2023
Sobi to Acquire CTI BioPharma
Biopharmaceuticals Mergers & Acquisitions
 HSMN NewsFeed - 9 May 2023
Omeq Medical Receives FDA Regulatory Clearance for its Smart Device for Epidural Injections
Devices FDA
 HSMN NewsFeed - 8 May 2023
HAPPE Spine Announces FDA Clearance for the INTEGRATE-C(TM) Interbody Fusion System
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 5 May 2023
Norlase Receives FDA 510(k) Clearance and CE Mark Approval For ECHO(TM) Green Pattern Laser
Devices Ophthalmology FDA
 HSMN NewsFeed - 4 May 2023
Soligenix Announces Positive Clinical Results from Compatibility Study of HyBryte(TM) in the Treatment of Cutaneous T-Cell Lymphoma
Biopharmaceuticals Oncology
 HSMN NewsFeed - 3 May 2023
Convergent Therapeutics Announces $90 Million Series A Financing to Advance the Clinical Development of Radiopharmaceuticals for the Treatment of Prostate Cancer and Other Solid Tumors
Biopharmaceuticals Oncology Venture Capital
 HSMN NewsFeed - 1 May 2023
Concept Medical received IDE approval to investigate safety and efficacy of its MagicTouch Sirolimus Coated Balloon Catheter for the treatment of small coronary artery disease
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 26 Apr 2023
CardieX Receives FDA 510(K) Clearance for a World-First Vascular Biometric Monitor - the CONNEQT Pulse
Devices Monitoring Cardiology FDA
 HSMN NewsFeed - 24 Apr 2023
Lilly to Divest BAQSIMI to Amphastar
Biopharmaceuticals Endocrinology Mergers & Acquisitions
 HSMN NewsFeed - 21 Apr 2023
AbbVie Announces Late-Breaking Results from Phase 3 Trial Evaluating Atogepant (QULIPTA(R)) for the Preventive Treatment of Episodic Migraine Among Patients with Prior Treatment Failure at the 2023 AAN Annual Meeting
Biopharmaceuticals Neurology
 HSMN NewsFeed - 20 Apr 2023
IceCure's ProSense System Used in Endometriosis Cryoablation Study That Demonstrated Efficacy Rate of 92.8% to Avoid Secondary Surgery
Devices Interventional
 HSMN NewsFeed - 18 Apr 2023
Neuspera Medical(R) Announces FDA Clearance of its System for Peripheral Nerve Stimulation
Devices Neurology FDA
 HSMN NewsFeed - 17 Apr 2023
OrthoFX(TM) Receives FDA Clearance for NiTime(TM) Aligners
Devices Dental FDA
 HSMN NewsFeed - 14 Apr 2023
Soligenix Provides Regulatory Update on HyBryte(TM)
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 13 Apr 2023
BioVentrix(R) Closes $48.5 Million Series A Financing
Devices Interventional Cardiology Venture Capital
 HSMN NewsFeed - 10 Apr 2023
Reach Neuro Receives FDA Breakthrough Device Designation for Device to Restore Arm and Hand Movement to Chronic Stroke Patients
Devices Neurology FDA
 HSMN NewsFeed - 6 Apr 2023
Icentia Receives U.S. Food and Drug Administration (FDA) Clearance for CardioSTAT(R)
Devices Cardiology FDA
 HSMN NewsFeed - 5 Apr 2023
Abyrx Receives Additional FDA Clearances for MONTAGE(R) Settable, Resorbable Bone Putty as Bone Void Filler and Cranial Bone Cement
Devices FDA
 HSMN NewsFeed - 30 Mar 2023
HistoSonics Announces First Ever Kidney Tumor Treatment Using Histotripsy
Devices Oncology
 HSMN NewsFeed - 30 Mar 2023
FDA approves Bioretec's RemeOs(TM) trauma screw as the first bioresorbable metal implant in the U.S. market
Devices Orthopaedic FDA
 HSMN NewsFeed - 29 Mar 2023
CoreLink Announces FDA Clearance of Siber(R) Ti--3D Printed SI Joint Fusion System
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 29 Mar 2023
Spiral Therapeutics Acquires Otonomy Assets to Boost Inner Ear Disorders Pipeline and Appoints Industry Leaders to Board
Biopharmaceuticals Acquisitions
 HSMN NewsFeed - 27 Mar 2023
BrainStorm Cell Therapeutics Announces FDA Advisory Committee Meeting to Review Biologics License Application for NurOwn(R) for the Treatment of ALS
Regenerative Medicine Neurology FDA
 HSMN NewsFeed - 21 Mar 2023
U.S. FDA Grants GrayMatters Health 510(k) Clearance to Market Prism for PTSD
Devices Neurology FDA
 HSMN NewsFeed - 20 Mar 2023
NuVasive Specialized Orthopedics Expands Indications of Precice Limb Lengthening System to Treat Pediatric Patients
Devices Orthopaedic FDA
 HSMN NewsFeed - 15 Mar 2023
Medtronic receives CE Mark approval for Affera(TM) Mapping and Ablation System to treat atrial arrhythmias
Devices Interventional Cardiology Regulatory
 HSMN NewsFeed - 14 Mar 2023
Over 1,000 Patients Enrolled in Landmark SELUTION DeNovo Study
Devices Interventional Cardiology
 HSMN NewsFeed - 8 Mar 2023
BlueWind Medical Announces Key Milestone as AMA Issues Unique Category III CPT Code for Subfascial Placement of Tibial Neurostimulators
Devices Urology Reimbursement
 HSMN NewsFeed - 3 Mar 2023
Aadi Bioscience Announces Leadership Transition
Biopharmaceuticals Oncology Personnel
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