Healthcare Industry News: ECG
News Release - May 22, 2006
Draeger Medical files 510(k) Pre-market Notification for New Patient-worn Monitoring System
Built on industry-standard WiFi technologyTELFORD, Pa.--(HSMN NewsFeed)--May 22, 2006--Draeger Medical today announced that it has submitted a 510(k) pre-market notification to the U.S. Food and Drug Administration (FDA) for its patient-worn monitoring system known as Infinity® TeleSmart. The Infinity TeleSmart system is a lightweight transceiver that is intended to monitor ECG and SpO2 in both adult and pediatric patients.
"With its built-in color display and alarm management capabilities, Infinity TeleSmart has been designed to address the challenges of today's busy ambulatory environment," says Yossi Elaz, vice president of research & development, Draeger Medical Global Business Unit for Patient Monitoring & IT.
Generally, a 510(k) is required by the FDA before a medical device may be marketed in the United States. Under the 510(k) process, the FDA's finding that a device is substantially equivalent to a legally marketed device permits the marketing of new devices such as the Infinity TeleSmart with specific indications for use.
Infinity TeleSmart is pending FDA 510(k) clearance and is not yet available commercially in the United States.
Infinity TeleSmart is not yet licensed in accordance with Canadian Medical Device Regulations.
This product is not yet CE-marked and may be placed on the market in the EC only after the conformity evaluation according to the Medical Device Directive 93/42/EEC is finalized.
About Draeger Medical
Draeger Medical AG & Co. KG is one of the world's leading manufacturers of medical equipment, the largest division of Draegerwerk AG (history dates back to 1889) and a 65:35 joint venture company between Draegerwerk AG and Siemens AG. The Company offers products, services and integrated CareArea(TM) Solutions throughout the patient care process - Emergency Care, Perioperative Care, Critical Care, Perinatal Care and Home Care. With U.S. headquarters in Telford, Pennsylvania and world headquarters in Luebeck, Germany, Draeger Medical employs nearly 6,000 people worldwide. Additional information is available on the Company's website www.draegermedical.com
Source: Draeger Medical
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