FDAnews Device Daily Bulletin
Jan. 31, 2005 | Vol. 2 No. 21
Medicare officials say roughly 500,000 Medicare beneficiaries can now receive coverage for expensive implantable cardioverter defibrillators - if they agree to release details about their cases to a database shared by hospitals.
Edwards Lifesciences has received conditional approval from the FDA to begin the first feasibility trial of its Cribier-Edwards percutaneous aortic heart valve.
FlowCardia, a developer of catheter-based systems to treat chronic total occlusions (CTOs) of coronary and peripheral arteries, has announced that the company's application for CE Marking of the CROSSER catheter has been approved for use in coronary arteries following failure to cross CTOs with conventional guidewire techniques.
InfuMedics and InSet Technologies have received a CE Mark for their Prometra Programmable Pump.
Neothermia has reached an agreement with Rubicor Medical for the dismissal of patent infringement and breach of contract litigation filed against Rubicor by Neothermia.
Springfield, Mass.-based firearms company Smith & Wesson launched its new, second-generation automated external defibrillator (AED), the Smith & Wesson Heartbeat AED. The new Smith & Wesson Heartbeat AED uses the "1-2-3" rescue approach, in which text messages and voice prompts walk the nonmedical user through the procedure.
Biotronik has announced the first worldwide implantation of a Philos II DR-T pacemaker and a Lexos DR-T ICD with advanced Home Monitoring Early Detection technology.
Endius has received additional patents for two revolutionary devices it developed and fine-tuned over the past four years.
Resonance Health has announced that its subsidiary, Inner Vision Biometrics, achieved FDA marketing approval for FerriScan, its novel noninvasive diagnostic test for liver iron concentration.
Doctors are working on a new fix for cleft palate, a common birth defect in which children are born with a gap in the roof of the mouth.
Bracco Diagnostics, which develops and manufactures a number of radiology, radiopharmaceutical and other diagnostic imaging products, and Amerinet, one of the leading health care group purchasing organizations in the U.S., have announced the inclusion of MultiHance (gadobenate dimeglumine) injection, 529 mg/mL, into the companies' previously established product purchasing agreement.
Framingham-Mass. based Transport Pharmaceuticals signed a license and collaboration agreement with pharmaceutical giant GlaxoSmithKline for Transport's iontophoretic device/drug combination system for the delivery of acyclovir, an approved cold-sore (herpes labialis) treatment.
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