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The FDA posted updated device recall information for the Ranger high-flow blood/fluid warming disposable sets on its Center for Biologics Evaluation and Research (CBER) website May 16.
Medical device regulations may be simplified this year if the director of the medical devices division of the Ministry of Health, Wilfried Reischl, gets his way.
St. Jude Medical, Inc. announced May 15 U.S. Food and Drug Administration (FDA) clearance of the EnSite System Version 6 software, which provides improved clinical capabilities for cardiac mapping and navigation during electrophysiology (EP) procedures.
X-Cell Medical, Inc. announced May 16 that the Company has completed enrollment in its ETHOS II multinational clinical trial to study the
safety and effectiveness of the ETHOS Coronary Stent System.
Thoratec Corporation, a world leader in products to treat cardiovascular disease, today said that the FDA has approved an IDE (Investigational Device Exemption) supplement that allows enrollment of up to an additional 90 patients in the Bridge-to-Transplantation (BTT) arm of the company's HeartMate II Phase II trial under a Continued Access Protocol (CAP).
St. Jude Medical, Inc. today announced U.S. Food and Drug Administration (FDA) approval of its Safire Ablation Catheter, and FDA clearance and European CE Mark for its Inquiry Optima PLUS Steerable Diagnostic Catheter.
Medtronic Inc. announced that it received FDA approval of its Concerto/Virtuoso line of implantable cardiac devices, its next generation of cardiac rhythm disease management products.
BioSeek, Inc., a leader in applying integrated human biology systems for developing new therapeutics, announced today that it has entered
into a non-exclusive agreement with Boston Scientific Corporation to profile compounds for potential applications in new products.
Abbott has entered into a licensing agreement with the Advanced Life Science Institute (ALSI) for its Pro-gastrin-releasing peptide (Pro-GRP), Abbott has announced.