IMDRF Round Up: Forum Plans Guidance on UDIs, SaMD March 21, 2017 IMDRF members discussed the planned guidance at the forum’s meeting. Read More
MHRA Issues Guidance on Leadless Pacemaker Clinical Studies March 21, 2017 MHRA says manufacturers should work to minimize bias and make inherent design limitations explicit. Read More
FDA Publishes List of Class II 510(k) Exemptions March 21, 2017 In some cases, the agency may limit exemptions to specific devices or tests within a given type. Read More
Japan’s MHLW Clears Novocure Second Generation Optune March 20, 2017 The device is lighter and smaller than the first generation. Read More
FDA Awards Marketing Clearance to Trovita Health Science’s Nutrition Delivery Device for Tube Feeding March 20, 2017 The device simplifies the tube feeding process. Read More
Masimo Gains CE Mark for Rad-97 Pulse CO-Oximeter and Connectivity Hub with Noninvasive Blood Pressure March 20, 2017 The device enables clinicians to measure arterial blood pressure for adult, pediatric and neonatal patients. Read More
Trump Budget Proposes Steep Hike in FDA User Fees March 20, 2017 The current user fee reauthorization package being considered by Congress for devices would aim to collect $183 million in fiscal 2018. Read More
FDA Approves Medtronic’s Melody Transcatheter Pulmonary Valve March 17, 2017 The device received FDA approval in 2010 for the treatment of failing pulmonary valve conduits. Read More
Toshiba Medical’s Cardiovascular Ultrasound Gains FDA Clearance March 17, 2017 This device is ideally suited for contrast, fetal, pediatric, stress echo and transesophageal echocardiography imaging. Read More
NICE Endorses Boston Scientific’s Battery Powered CRT-D Devices March 17, 2017 EnduraLife battery technology has nearly two times the usable battery capacity. Read More
Gottlieb Nomination Draws Positive Reviews, And Some Questions March 17, 2017 AdvaMed said Gottlieb’s background and commitment to technological innovation make him a strong choice. Read More
At Last: New EU MDR Regulations Near Final Approval March 17, 2017 After two decades of work, the EU’s new medical device and in vitro regulations are nearing their final approval stretch. Read More