Regulatory and Legal
Sep 20, 2016
Marie Thibault Boston Scientific's Lotus Edge valve has received CE Mark. Lotus Edge, the next-generation transcatheter aortic valve (TAVR) from Boston...
Sep 13, 2016
Marie Thibault 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
Marie Thibault 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
Marie Thibault 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
Marie Thibault 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
Marie Thibault FDA has approved Edwards Lifesciences' Sapien 3 THV for use in intermediate-risk aortic stenosis patients. FDA has approved the Sapien 3...
Aug 11, 2016
Marie Thibault After much deliberation and years of waiting, FDA this week released two draft guidances on when a modification warrants a new 510(k)...
Aug 10, 2016
Marie Thibault The FDA approval covers MR-conditional labeling for Emblem S-ICD systems that have already been implanted. This week, FDA granted regulatory...
Aug 03, 2016
Marie Thibault Endologix's Nellix EndoVascular Aneurysm Sealing (EVAS) system, is a hotly anticipated device for which patients and clinicians may...
Aug 02, 2016
Marie Thibault ReliantHeart's aVAD intraventricular left ventricular assist device has received CE Mark. ReliantHeart’s new left ventricular assist device (...