Food & Drug Administration (FDA)
FDA rejects AcelRx’s request for meeting on pain drug device
FDA expands indication for Medtronic’s StealthStation nav suite
Globus: Synthes witness faked CV | Medtech legal news for the week of May 4, 2015
FDA approves MRI-safe SCS device from St. Jude Medical
FDA closes out CryoLife warning letter, PerClot trial launches
FDA panel on aneurysm devices | Regulatory news for the week of April 27, 2015
UPDATE: Medtronic agrees to stop making SynchroMed drug pump
Maquet’s TigerPaw II recall is Class I
Medtech approvals: FDA releases February 2015 PMAs
Summary of PMA Originals & Supplements Approved
Originals: 2
Supplements: 62
Summary of PMA Originals Under Review
Total Under Review: 62
Total Active: 29
Total On Hold: 33
Summary of PMA Supplements Under Review
Burr introduces fast-track FDA bill
A new Senate bill introduced yesterday would create a fast-track program at the FDA for breakthrough medical devices
The bill, S. 1077 or " A bill to provide for expedited development of and priority review for breakthrough devices," was sponsored by Sen. Richard Burr (R-N.C.) and co-sponsored by Sens. Orrin Hatch (R-Utah) and Michael Bennet (D-Colo.).