News
Jul 15, 2015
Marie Thibault Ready or not, here it comes . . . value-based care. The idea of value-based care has generated plenty of buzz over the past several years, but...
Jul 14, 2015
Marie Thibault Over the past several months, "right to try" laws have been passed in many states, and now similar legislation has made its way to...
Jul 13, 2015
Marie Thibault Public Citizen, a public advocacy group, wants to see a Sanofi surgical device taken off the market almost 20 years after it received FDA...
Jul 09, 2015
Marie Thibault It's time for another round of the reauthorization process needed for the next version of the Medical Device User Fee Act (MDUFA). To kick off...
Jul 08, 2015
Marie Thibault A prototype of the PURE EP System from BioSig Technologies, Inc., designed to acquire accurate cardiac recordings. Cardiac arrhythmias are a...
Jul 06, 2015
Marie Thibault The Essure permanent birth control device is set to receive more scrutiny. FDA recently announced that it will convene a September 24 meeting...
Jul 02, 2015
Marie Thibault Legislators have considered several pieces of legislation related to medical innovation this session, including the "21st Century Cures...
Jul 01, 2015
Marie Thibault The Implantable Miniature Telescope implant from VisionCare Ophthalmic Technologies, Inc. is used in patients with end-stage age-related...
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Marie Thibault As part of its unique device identifier rule, FDA has published draft guidance, "Unique Device Identification: Direct Marking of Devices,...