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
Powers Medical Devices Cited for Supplier Evaluations March 17, 2017 The FDA cited Powers Medical Devices in a form 483 for failing to implement its supplier evaluation or internal audit procedures. Read More
Device Trade Group Identifies Highest-Priority FDA Guidance March 16, 2017 Three of the guidances involve IVDs. Read More
Medtronic Joins Call for Anti-Kickback Statute Safe Harbor March 16, 2017 The proposed safe harbor would facilitate more flexible payments between device manufacturers and buyers. Read More
FDA Cites Lusys Labs for Design Control, Other Procedures March 16, 2017 Inspectors observed the company had not established design control procedures for several of its Zika virus tests. Read More
Grassley Questions EpiPen Rival’s Pricing Policy March 16, 2017 This pricing policy raises similar concerns to those for the EpiPen. Read More