LiveNova’s Epilepsy Device Gets Expanded Approval for Use With MRIs June 29, 2017 Under the expanded access, the AspireHC and AspireSR models can now be used with MRIs. Read More
Better Use of Existing Data Could Identify Safety Issues Sooner: CHOP Reports June 28, 2017 Identifying the trends earlier, researchers wrote, could have saved about $1 billion between 2010 and 2014. Read More
Senate Healthcare Bill Would Repeal Medical Device Tax June 28, 2017 The tax is currently on a two-year moratorium that began in January 2015. Read More
FDA Hits Oakworks Over Unreported Changes, Record-Keeping, Complaints June 28, 2017 The firm made alterations to devices without reporting the changes in writing to the FDA. Read More
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