Dec 29, 2016
CDRH has publicized its resolution list for the new year, issuing an A-list of its top priorities for final and draft guidance in fiscal year...
Dec 13, 2016
Almost a year after its draft guidance proposing public notification of emerging signals for postmarket medical devices, FDA is issuing final...
Dec 06, 2016
U.S. Senators Elizabeth Warren (D-MA) and Chuck Grassley (R-IA) recently introduced bipartisan legislation to make some kinds of hearing aids...
Oct 25, 2016
CoreValve Evolut R 34 mm transcatheter aortic valve replacement is now the largest FDA-approved valve size.
FDA has approved Medtronic's...
Sep 20, 2016
Boston Scientific's Lotus Edge valve has received CE Mark.
Lotus Edge, the next-generation transcatheter aortic valve (TAVR) from Boston...
Sep 13, 2016
In an update after last week's warning from FDA about ovarian cancer screening tests, Abcodia, which sells the ROCA Test, announced it is...
Sep 09, 2016
Earlier detection of cancer is a good thing, right? So why did FDA just warn against ovarian cancer screening tests?
This week, the...
Aug 30, 2016
Device makers have three more years to meet a particular requirement of the Unique Device Identifier (UDI) rule. FDA has issued final guidance...
Aug 23, 2016
ImPACT and ImPACT Pediatric have been FDA-cleared for use in assessing a person's cognitive function after a suspected concussion or brain...
Aug 18, 2016
FDA has approved Edwards Lifesciences' Sapien 3 THV for use in intermediate-risk aortic stenosis patients.
FDA has approved the Sapien 3...