November 6, 2018 By Danielle Kirsh Leave a Comment ANVISA report shows increase in medical device modification submissions
November 5, 2018 By Danielle Kirsh Leave a Comment South Korean medical device regulators to align quality requirements with ISO 13485:2016
November 2, 2018 By Chris Newmarker Leave a Comment FDA to speed up review of medical products for U.S. military
November 1, 2018 By Danielle Kirsh Leave a Comment Gogoa Mobility Robots wins CE Mark for Hank exoskeleton
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 25, 2018 By Danielle Kirsh Leave a Comment KPMG and RAPS finds many medical device companies underprepared for European MDR
October 24, 2018 By Heather Thompson Leave a Comment FDA grants breakthrough device status to MediBeacon
October 24, 2018 By Danielle Kirsh Leave a Comment Chinese regulators add more medical devices, IVDs to clinical trial exemption list
October 23, 2018 By Danielle Kirsh Leave a Comment Civco Radiotherapy wins 510(k), CE Mark for Solstice SRS immobilization system
October 23, 2018 By Danielle Kirsh Leave a Comment Changes to ISO 14155 standard for medical device clinical investigations expected in 2019
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
