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Medical Devices

FDA grants a humanitarian-use device designation to Cyberkinetics Neurotechnology Systems for its An...

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Medical Devices

Boston Scientific acknowledges an internal study found an increased risk of late stent thrombosis wi...

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Medical Devices

FDA has given 510(k) clearance to Trinity Biotech for its Uni-Gold H. pylori one-step test. Company ...

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Medical Devices

C.R. Bard, Inc., Murray Hill, NJ, has received 510(k) clearance from FDA for its Memotherm Flexx bil...

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Medical Devices

UltraTouch Corp. says it will ask FDA for expedited medical device development approval for its Palp...

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Medical Devices

For the third time within a week, Boston Scientific Corp., which has had problems with FDA and the U...

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Medical Devices

It is the second Boston Scientific device to be approved within a week, further easing concerns that...

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Medical Devices

FDA has given marketing clearance for Estech, Inc.'s Remote Access Perfusion Cannula, a new multi-fu...

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Medical Devices

The Health Industry Manufacturers Association appointed Ronald W. Dollens, President and CEO of Guid...

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Medical Devices

Study data presented at the recent American College of Cardiology Meeting showed that Radiance Medic...

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Medical Devices

Guidant says doctors should make monthly checks of patients with certain of its pacemakers because a...

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Medical Devices

The Health Industry Manufacturers Association told Congress 3/18 it has changed its position on FDA ...

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Medical Devices

FDA has given marketing clearance to Micronix Surgical Corp.'s Micro-Arthroscope, a disposable micro...

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Medical Devices

Thermal Medical Imaging has received FDA approval to file a modular PMA for its Thermal Breast Imagi...

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Medical Devices

Phase II clinical studies of the non-laser Refractec Corneal Shaping System tested on patients with ...

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Medical Devices

Despite pleas from outgoing CDRH director Bruce Burlington in one-on-one calls to selected CEOs abou...

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Medical Devices

The Medical Device Manufacturers Association told the White House's Office of Management and Budget ...

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Medical Devices

Results from the NIH-sponsored Multicenter Unsustained Tachycardia Trial presented at recent America...

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Medical Devices

FDA has approved Trinity Biotech's Uni-Gold Strep A test. The test is a rapid, qualitative assay for...

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Medical Devices

Draxis Health, Mississauga, Ontario, Canada, files a 510(k) with FDA to market Iodine-125 brachyther...