News
Jun 29, 2015
Marie Thibault   If you thought the definition of a "surgical gown" was obvious, think again. FDA has set out its policy on what is and is not a...
Jun 25, 2015
Marie Thibault As part of its unique device identifier rule, FDA has published draft guidance, "Unique Device Identification: Direct Marking of Devices,...
Jun 24, 2015
Marie Thibault FDA has published draft guidance to give industry a better idea of what the agency looks at when deciding whether to approve an Investigational...
Jun 24, 2015
Marie Thibault The Medtronic CoreValve Evolut R transcatheter aortic valve replacement system has received FDA approval. Medtronic and Edwards Lifesciences...
Jun 23, 2015
Marie Thibault An article published in the Journal of the American Medical Association on June 23 points to a low rate of ICD implantation in elderly...
Jun 22, 2015
Marie Thibault   Wicab, Inc.'s BrainPort V100, for blind patients, has received FDA approval. Blind patients in the United States just gained access to a...
Jun 18, 2015
Marie Thibault The U.S. House of Representatives today passed the "Protect Medical Innovation Act" (H.R. 160), legislation that includes language to...
Jun 18, 2015
Marie Thibault Edwards Lifesciences' Sapien 3 transcatheter aortic valve has received FDA approval early. The FDA has approved the next-generation Sapien 3...
Jun 18, 2015
Marie Thibault Wearables and mobile apps have been infiltrating the traditional medical device industry bit by bit, and clinical trial software company...
Jun 15, 2015
Marie Thibault New data published in the Journal of the American College of Cardiology sheds more light on the benefits of the Watchman left atrial appendage...