Royal Philips Gets FDA Clearance for Latest Radiology Platform June 28, 2017 The platform has been available outside of the United States since last November. Read More
FDA Cites Four New York Firms Over Procedures, Records June 27, 2017 The FDA’s observations primarily focused on CAPA issues and record-keeping. Read More
Royal Philips to Buy Electrical Geodesics for $36.7 Million June 27, 2017 Electrical Geodesics will put the deal to a shareholder vote. Read More
FDA Hits Kronner Over Complaints, Reporting Procedures June 27, 2017 The company failed to document verification or validation of corrective actions taken in response to two complaints. Read More
Abbott Warns of Problems With HeartMate 3 Pump June 27, 2017 The company will update specifications and manufacturing processes to correct the problem. Read More
FDA Clears Summit’s Jaw Fracture Recovery Device for Marketing June 26, 2017 The device is safer and less time-consuming than wire devices. Read More
Cardiac Devices Pose Cybersecurity Challenges, Study Finds June 26, 2017 A study of four major pacemaker manufacturers found thousands of security risks. Read More
Senate Healthcare Bill Would Repeal Medical Device Excise Tax June 26, 2017 The House bill included the same provision. Read More
Device Reprocessing Market to Reach $1.7 Billion by 2022 June 26, 2017 Regulatory changes in France and Japan will drive the growth. Read More
Insulin Management Software Wins FDA Nod June 23, 2017 The product has received FDA clearance. Read More
Sommetrics Wins Health Canada Nod for Non-Invasive Sleep Apnea Device June 23, 2017 The device maintains an open airway during sleep. Read More
Brazil’s ANVISA Now Accepts Both Electronic and Paper Submissions June 23, 2017 Medical device registration submissions can now be submitted in multiple formats. Read More