November 20, 2018 By Danielle Kirsh Leave a Comment Cook Medical wins humanitarian nod from FDA for Flourish pediatric esophageal atresia device
November 2, 2018 By Chris Newmarker Leave a Comment FDA to speed up review of medical products for U.S. military
October 30, 2018 By Danielle Kirsh Leave a Comment Biotronik receives FDA approval for covered coronary stent
October 26, 2018 By Danielle Kirsh Leave a Comment FDA clarifies human subject requirements for clinical investigations
October 24, 2018 By Heather Thompson Leave a Comment FDA grants breakthrough device status to MediBeacon
October 23, 2018 By Danielle Kirsh Leave a Comment Civco Radiotherapy wins 510(k), CE Mark for Solstice SRS immobilization system
October 22, 2018 By Danielle Kirsh Leave a Comment FDA clears MC3 Cardiopulmonary’s Crescent ECMO catheter
October 22, 2018 By Danielle Kirsh Leave a Comment FDA announces key guidance publication plans for 2019
October 19, 2018 By Danielle Kirsh Leave a Comment FDA launches pilot to expand special 510(k) market pathway
October 18, 2018 By Danielle Kirsh Leave a Comment Eximo Medical receives FDA clearance for laser system
October 12, 2018 By Chris Newmarker Leave a Comment Senators question basis for FDA’s digital health pre-cert pilot
October 11, 2018 By Heather Thompson Leave a Comment FDA to revamp medtech cybersecurity — with your help
