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Healthcare News Roundup: FDA

 HSMN NewsFeed - 3 Dec 2010
CONMED Corporation Receives Clearance From FDA for Novel Tissue Fusion System
Devices Surgery FDA
 HSMN NewsFeed - 3 Dec 2010
Oceana Therapeutics Announces FDA Advisory Committee Recommends Approval of Solesta(TM)
Biopharmaceuticals FDA
 HSMN NewsFeed - 3 Dec 2010
Cell Therapeutics Files Appeal on FDA Decision on New Drug Application (NDA) for Pixantrone to Treat Relapsed/Refractory Aggressive Non-Hodgkin's Lymphoma
Biopharmaceuticals Oncology
 HSMN NewsFeed - 2 Dec 2010
US FDA Advisory Committee Makes Recommendation on New Drug Application for Vandetanib in Advanced Medullary Thyroid Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 2 Dec 2010
Sagent Pharmaceuticals Announces FDA Approval of Midazolam Injection, USP
Biopharmaceuticals FDA
 HSMN NewsFeed - 2 Dec 2010
MedPro Safety Products Receives FDA Market Clearance for Passive Safety Winged Blood Collection Set
Devices FDA
 HSMN NewsFeed - 2 Dec 2010
Medtronic Announces CD HORIZON(R) System 510k Pedicle Screw Clearance for Adolescent Idiopathic Scoliosis
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 2 Dec 2010
FDA Accepts Guided Therapeutics' Non-Invasive Cervical Cancer Scanner PMA Application for Review
Devices Diagnostics Oncology FDA
 HSMN NewsFeed - 2 Dec 2010
Abiomed Receives Conditional FDA Approval for Study with Impella 2.5 in Reducing Heart Muscle Damage Following PCI in STEMI Patients
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 2 Dec 2010
Tryton Announces Investigational Device Exemption Conditional Approval from FDA to Conduct U.S. Pivotal Study of Side Branch Stent
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 2 Dec 2010
Covidien Receives FDA 510(k) Clearance for the iDrive(TM) Powered Stapling System
Devices Surgery FDA
 HSMN NewsFeed - 1 Dec 2010
Cubist Pharmaceuticals Receives FDA Approval for 2-Minute IV Injection of CUBICIN
Biopharmaceuticals FDA
 HSMN NewsFeed - 1 Dec 2010
Octapharma USA Focuses on Urgent Surgeries as FDA Approves octaplex(R) for Fast Track Development
Biopharmaceuticals Surgery FDA
 HSMN NewsFeed - 30 Nov 2010
X-spine Announces New FDA Product Clearance
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 30 Nov 2010
Inspire Medical Systems Announces FDA approval for Pivotal Clinical Trial
Devices Neurology FDA
 HSMN NewsFeed - 30 Nov 2010
Syneron Announces US and Canada Launch of CO2RE System Following FDA and Health Canada Clearance for the System
Devices FDA Regulatory
 HSMN NewsFeed - 23 Nov 2010
FDA Approves Movement Disorder Drug from CNS Therapeutics: Gablofen(R) (Baclofen Injection) for the Treatment of Severe Spasticity
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 23 Nov 2010
BG Medicine Announces FDA 510(k) Clearance of its Galectin-3 Test for Use in Patients with Chronic Heart Failure
Diagnostics Cardiology FDA
 HSMN NewsFeed - 23 Nov 2010
Hologic Receives FDA Approvable Letter for Selenia Dimensions (3-D) Digital Mammography Tomosynthesis System
Devices Radiology Oncology FDA
 HSMN NewsFeed - 22 Nov 2010
Impax Laboratories Receives Tentative FDA Approval for Generic Cymbalta(R) Delayed-Release 20, 30 and 60 mg Capsules
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 19 Nov 2010
Xanodyne Pharmaceuticals, Inc. To Voluntarily Withdraw Darvon(R) and Darvocet-N(R) Products
Biopharmaceuticals FDA
 HSMN NewsFeed - 17 Nov 2010
Titan Spine Receives Regulatory Clearance to Launch Endoskeleton(R) TO PLIF and Oblique Interbody Fusion Devices
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 16 Nov 2010
Canon U.S.A.’s Newest Retinal Camera, the CR-2 Digital Non-Mydriatic Digital Retinal Camera, Receives FDA Clearance
Devices Ophthalmology FDA
 HSMN NewsFeed - 15 Nov 2010
FDA Approves Eisai’s Halaven(TM) (Eribulin Mesylate) Injection for Treatment of Metastatic Breast Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 11 Nov 2010
FDA Approves EGRIFTA(TM) (Tesamorelin for Injection): The First and Only Treatment for the Reduction of Excess Abdominal Fat in HIV-Infected Patients With Lipodystrophy
Biopharmaceuticals FDA
 HSMN NewsFeed - 10 Nov 2010
FDA Approves Bionovo's Clinical Development Plan for Menerba
Biopharmaceuticals FDA
 HSMN NewsFeed - 9 Nov 2010
Semafore Pharmaceuticals Receives FDA Orphan Drug Designation for SF1126 in the Treatment of Chronic Lymphocytic Leukemia
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 8 Nov 2010
Carl Zeiss Meditec Receives FDA Clearance for the IOLMaster 500 Biometer
Devices Ophthalmology FDA
 HSMN NewsFeed - 4 Nov 2010
Bovie Medical Corporation Announces 510(k) Application for J-Plasma(TM) Handpiece with Retractable Cutting Features
Devices Surgery FDA
 HSMN NewsFeed - 4 Nov 2010
Covidien Receives FDA 510(k) Clearance for Kendall SCD(TM) Compression Comfort Sleeve and Kendall SCD(TM) 700 Series Controller
Devices FDA
 HSMN NewsFeed - 3 Nov 2010
IDEV Technologies Announces FDA 510(k) Clearance for SUPERA VERITAS
Devices Interventional FDA
 HSMN NewsFeed - 2 Nov 2010
Cadence Pharmaceuticals Announces FDA Approval of OFIRMEV (acetaminophen) injection for the Management of Pain and Fever
Biopharmaceuticals FDA
 HSMN NewsFeed - 2 Nov 2010
ArthroCare Receives FDA Clearance for SpeedFix
Devices Orthopaedic FDA
 HSMN NewsFeed - 1 Nov 2010
U.S. Food and Drug Administration Clears Way for Multi-Center Clinical Trial of Hansen Medical Sensei(R) X Robotic Catheter System for Treatment of Atrial Fibrillation
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 1 Nov 2010
Medtronic Receives FDA Approval of Talent Captivia(R) System for Endovascular Treatment of Thoracic Aortic Aneurysms
Devices Interventional FDA
 HSMN NewsFeed - 1 Nov 2010
Neogenix Oncology(R) Receives FDA Orphan Drug Status for Ensituximab (NPC-1C) for Treatment of Pancreatic Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 1 Nov 2010
Ortho Clinical Diagnostics Receives FDA Clearance for Intact Parathyroid Hormone Assay
Diagnostics FDA
 HSMN NewsFeed - 30 Oct 2010
Novartis Drug Afinitor(R) Approved by FDA as First Medication for Children and Adults with a Benign Brain Tumor Associated with Tuberous Sclerosis
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 30 Oct 2010
APP Pharmaceuticals Announces Approval of Metoprolol Tartrate Injection, USP
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 30 Oct 2010
Forest Announces FDA Approval of Teflaro(TM) (ceftaroline fosamil) for the Treatment of Community-Acquired Bacterial Pneumonia and Acute Bacterial Skin and Skin Structure Infection
Biopharmaceuticals FDA
 HSMN NewsFeed - 30 Oct 2010
AVANIR Pharmaceuticals Announces FDA Approval of NUEDEXTA
Biopharmaceuticals FDA
 HSMN NewsFeed - 29 Oct 2010
FDA Classifies Previous Field Action of Medtronic Surgical Device as Class I Recall
Devices Surgery Product Recall FDA
 HSMN NewsFeed - 28 Oct 2010
ArthroCare Receives FDA Clearance for Spartan PEEK Suture Implant
Devices Surgery Orthopaedic
 HSMN NewsFeed - 28 Oct 2010
EpiCept Corporation and FDA Agree on Development Plan for Ceplene(R)
Biopharmaceuticals Oncology
 HSMN NewsFeed - 22 Oct 2010
Warner Chilcott Announces FDA Approval of New Oral Contraceptive
Biopharmaceuticals FDA
 HSMN NewsFeed - 21 Oct 2010
Medtronic Announces New Inflatable Bone Tamp for Treatment of Vertebral Compression Fractures
Devices FDA Orthopaedic Neurosurgery
 HSMN NewsFeed - 21 Oct 2010
Boston Scientific Announces FDA Clearance and CE Mark Approval for Advanix Biliary Stents
Devices Interventional FDA
 HSMN NewsFeed - 20 Oct 2010
Burton Medical Receives FDA Clearance for its AIM-200(R) O.R. Light Source for Surgical Operating Rooms
Devices Surgery FDA
 HSMN NewsFeed - 20 Oct 2010
FDA Approves Pradaxa, Marking a Major Milestone to Reduce the Risk of Stroke in Patients with Non-Valvular Atrial Fibrillation
Biopharmaceuticals Cardiology Neurology FDA
 HSMN NewsFeed - 20 Oct 2010
PinPointe FootLaser Receives FDA Clearance for the Treatment of Nail Fungus (Onychomycosis)
Devices FDA
 HSMN NewsFeed - 19 Oct 2010
Devon Medical Products Receives FDA 510(k) Clearance for CircuFlow Sequential Compression Pump Models
Devices FDA
 HSMN NewsFeed - 18 Oct 2010
U.S. Food and Drug Administration Approves BARACLUDE(R) (entecavir) as a Treatment for Chronic Hepatitis B Patients with Evidence of Decompensated Liver Disease
Biopharmaceuticals FDA
 HSMN NewsFeed - 15 Oct 2010
FDA Approves H.P. Acthar(R) Gel for the Treatment of Infantile Spasms
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 15 Oct 2010
Medtronic Clinical Trial Receives FDA Approval to Evaluate New CoreValve(R) System for Aortic Valve Implantation
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 15 Oct 2010
Watson's Generic Version of Lotrel(R) Receives FDA Approval
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 15 Oct 2010
Mylan Receives Approvals for Generic Versions of Hyzaar(R) and Cozaar(R)
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 14 Oct 2010
Talecris Biotherapeutics Receives FDA Approval for Gamunex(R)-C
Biopharmaceuticals FDA
 HSMN NewsFeed - 13 Oct 2010
Bio-Rad and Axis-Shield Announce FDA Clearance and U.S. Launch of an Anti-CCP Test for Rheumatoid Arthritis for Bio-Rad's BioPlex 2200 System
Diagnostics FDA
 HSMN NewsFeed - 11 Oct 2010
Warner Chilcott Announces FDA Approval of Next Generation Actonel
Biopharmaceuticals FDA
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