News
Dec 29, 2016
Marie Thibault CDRH has publicized its resolution list for the new year, issuing an A-list of its top priorities for final and draft guidance in fiscal year...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
Marie Thibault Almost a year after its draft guidance proposing public notification of emerging signals for postmarket medical devices, FDA is issuing final...
Dec 08, 2016
Marie Thibault The Edwards-CardiAQ mitral valve is anticipated to receive CE Mark in 2018. 2017 is set to be a transformative year for Edwards Lifesciences'...
Dec 06, 2016
Marie Thibault U.S. Senators Elizabeth Warren (D-MA) and Chuck Grassley (R-IA) recently introduced bipartisan legislation to make some kinds of hearing aids...
Dec 02, 2016
Marie Thibault Boston Scientific's Lotus Edge TAVR system received CE Mark in September 2016 but does not yet have FDA approval. Boston Scientific has signed...
Nov 09, 2016
Marie Thibault Donald Trump has won the U.S. presidency. Now what? What will Trump's presidency mean for medtech? One analyst views it as a minor positive for...
Nov 01, 2016
Marie Thibault Durability has long been a concern for transcatheter aortic valves (TAVR) since long-term experience with the technology is still limited, at...
Nov 01, 2016
Marie Thibault A device focused on expanding the applications of optical coherence tomography (OCT) is the winner of the 2016 Dare-to-Dream Medtech Design...
Oct 31, 2016
Marie Thibault The Amplatzer PFO Occluder from St. Jude Medical has been approved by FDA to close patent foramen ovale in ischemic stroke patients. St. Jude...
Oct 28, 2016
Marie Thibault St. Jude Medical has paused Nanostim leadless cardiac pacemaker implants. St. Jude Medical has pressed pause on all implants of its Nanostim...