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Medical Devices
FDA grants a humanitarian-use device designation to Cyberkinetics Neurotechnology Systems for its An...
Medical Devices
Boston Scientific acknowledges an internal study found an increased risk of late stent thrombosis wi...
Medical Devices
FDA has given 510(k) clearance to Trinity Biotech for its Uni-Gold H. pylori one-step test. Company ...
Medical Devices
C.R. Bard, Inc., Murray Hill, NJ, has received 510(k) clearance from FDA for its Memotherm Flexx bil...
Medical Devices
UltraTouch Corp. says it will ask FDA for expedited medical device development approval for its Palp...
Medical Devices
For the third time within a week, Boston Scientific Corp., which has had problems with FDA and the U...
Medical Devices
It is the second Boston Scientific device to be approved within a week, further easing concerns that...
Medical Devices
FDA has given marketing clearance for Estech, Inc.'s Remote Access Perfusion Cannula, a new multi-fu...
Medical Devices
The Health Industry Manufacturers Association appointed Ronald W. Dollens, President and CEO of Guid...
Medical Devices
Study data presented at the recent American College of Cardiology Meeting showed that Radiance Medic...
Medical Devices
Guidant says doctors should make monthly checks of patients with certain of its pacemakers because a...
Medical Devices
The Health Industry Manufacturers Association told Congress 3/18 it has changed its position on FDA ...
Medical Devices
FDA has given marketing clearance to Micronix Surgical Corp.'s Micro-Arthroscope, a disposable micro...
Medical Devices
Thermal Medical Imaging has received FDA approval to file a modular PMA for its Thermal Breast Imagi...
Medical Devices
Phase II clinical studies of the non-laser Refractec Corneal Shaping System tested on patients with ...
Medical Devices
Despite pleas from outgoing CDRH director Bruce Burlington in one-on-one calls to selected CEOs abou...
Medical Devices
The Medical Device Manufacturers Association told the White House's Office of Management and Budget ...
Medical Devices
Results from the NIH-sponsored Multicenter Unsustained Tachycardia Trial presented at recent America...
Medical Devices
FDA has approved Trinity Biotech's Uni-Gold Strep A test. The test is a rapid, qualitative assay for...
Medical Devices
Draxis Health, Mississauga, Ontario, Canada, files a 510(k) with FDA to market Iodine-125 brachyther...
