FDAnews Device Daily Bulletin
Feb. 23, 2005 | Vol. 2 No. 38
Boston Scientific has completed enrollment in its ATLAS clinical trial, a global, multicenter, pivotal study designed to support FDA approval of the Taxus Liberte stent system.
Saft, a global multitechnology battery specialist, has announced that Cardiac Science, a manufacturer of life-saving automatic external defibrillators (AEDs), awarded Saft a three-year contract to be the turnkey provider of a complete lithium battery power pack for Cardiac Science's G3 line of Powerheart AEDs.
Exactech announced the successful initial implantation of Optecure in a recent spinal fusion surgery.
Closure Medical has received the European Union's CE Mark approval for its proprietary OMNEX Surgical Sealant, the company's first product indicated for use inside the body.
Rochester Medical announced market introduction of its Closed System Intermittent Catheter in both Hydrophilic Intermittent and Antibacterial Hydrophilic Intermittent configurations.
Chembio Diagnostics announced that it submitted an application to the FDA for premarket approval (PMA) of its Sure Check HIV and HIV Stat-Pak rapid HIV tests.
Biotechnology funding organization Cape Biotech has committed R6.7 million to DISA Vascular, a Cape-based medical device company that develops innovative vascular devices for the treatment of heart and peripheral vascular disease.
The Medical House, an orthopedic devices and drug delivery company, and BioPartners, the global biopharmaceuticals company, announced a 10-year agreement for license and supply of The Medical House's GH1 reusable, spring-powered, needle-free delivery system for the delivery of BioPartners' human growth hormone product, Valtropin.
Immunodiagnostic Systems bought the BoneTRAP diagnostic assay technology and related assets of Finland's Suomen Bioanalytiikka Oy for a maximum of £1.5 million.
Roche Diagnostics of Indianapolis, Ind., dismissed a complaint filed in U.S. District Court, Southern District of Indiana against former supplier Access Diabetic Supply of Pompano Beach, Fla.
Delphi Medical Systems, a subsidiary of Delphi, entered into a five-year agreement with Cardinal Health to develop and manufacture respiratory devices for Cardinal Health's Respiratory Care business.
CoreValve announced that its proprietary percutaneous ReValving system, which features a pericardium aortic heart valve mounted in a self-expanding frame, has been implanted successfully for the first time in Europe in the cardiac catheterization laboratory at the Heart Center, Siegburg, Germany.
BioCardia announced the approval of its 510(k) application by the FDA for using its Morph Universal Deflectable Guide Catheter in peripheral cardiovascular surgical applications.
Lumenis, a global developer, manufacturer and seller of laser and light-based devices for medical, aesthetic, ophthalmic, dental and veterinary applications, reported that it has received a notification - referred to as a "Wells Notice" -- from the staff of the Boston District Office of the SEC in connection with the staff's ongoing investigation into various accounting
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