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Panel Splits on CardioMEMS Device

[ Price : $8.95]

Members of FDAs Circulatory Systems Devices Advisory Panel vote that the benefits of the CardioMEMS Champion implantable pressure ...

FDA Approves Pediatric Use for Liposorber Apheresis System

[ Price : $8.95]

FDA approves a Kaneka America Humanitarian Device Exemption for its Liposorber LA-15 System and its use in treating pediatric pati...

FDA OKs Neuros IND for Amputee Limb Pain

[ Price : $8.95]

FDA grants approval of a Neuro Medical IDE for a safety and efficacy trial of its Altius System High Frequency Nerve Block technol...

Gilead Ends Successful Idelalisib CLL Trial Early

[ Price : $8.95]

Gilead says it is ending a Phase 3 trial of idelalisib in chronic lymphocytic leukemia early because the drug showed highly statis...

FDA Clears Maquet Medical Volista Surgical Lighting

[ Price : $8.95]

FDA clears a Maquet Medical Systems 510(k) for the Volista Surgical Lighting System.

Democrats Decry Shutdown Effect on Salmonella Outbreak

[ Price : $8.95]

Three House Energy and Commerce Committee Democrats say the government shutdown is endangering the health of the public because fe...

FDA Accepts BioDelivery Sciences NDA for Bunavail

[ Price : $8.95]

FDA accepts a BioDelivery Sciences NDA for Bunavail (buprenorphine naloxone buccal film) for maintenance treatment of opioid depen...

Public Sources Have Insufficient Trial Info: Study

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German researchers in the Institute for Quality and Efficiency in Healthcare say clinical study reports should be made publicly av...

Patient Advocates Want to Work with FDA on Rare Disease Pilot

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Parent Project Muscular Dystrophy calls on FDA to collaborate with it on a rare disease benefit/risk pilot program focused initial...

Brainlab Gains Clearance for Airo Mobile CT Scanner

[ Price : $8.95]

FDA clears a Brainlab 510(k) to market Airo Mobile Intraoperative CT scanner for interoperative imaging.