Unwrapped Cannulas Prompt Warning for Grams June 10, 2016 The FDA issued Grams Medical a warning letter for sterilization problems related to its reusable cannula tips. Read More
Theranos Voids Two Years’ Worth of Blood-Test Results June 10, 2016 In the ongoing Theranos saga, the company has now rescinded test results from the past two years for its Edison blood-testing diagnostics. Read More
EU Device Regulations Advance, As Trilogue Members Agree to Updates June 10, 2016 It’s the final countdown for those long-awaited updates to regulations governing medical devices and in vitro diagnostics in Europe. Read More
Sandstone Diagnostics Earns FDA Clearance June 9, 2016 Trak will be available for purchase in October. Read More
Lumenis Introduces UltraPulse DUO Platform June 9, 2016 The platform is intended for transoral laser microsurgery. Read More
Joylux Nabs Health Canada Approval for vSculpt June 9, 2016 The device will be exhibited at the Neighbourhood Pharmacy Association of Canada in Toronto. Read More
GenMark Nabs CE Mark for ePlex System June 9, 2016 ePlex is a “sample-to-answer” system that detects numerous molecular targets on one test cartridge. Read More
Astute Medical Gains FDA Clearance for NephroCheck Test June 9, 2016 The test can determine AKI risk within 12 hours post administration. Read More
Stentys Nabs FDA Clearance for Longest Version of Xposition Stent June 8, 2016 The clearance bolsters the company’s existing Xposition stent portfolio. Read More
Seegene to Introduce Universal SG Fluorescence Oligo System June 8, 2016 The new technology is designed to streamline real-time PCR assay development. Read More
MẌ Orthopedics Scores FDA Clearance June 8, 2016 The screw provides higher levels of compression against traditional bone screws. Read More
Gore Earns CE Mark for its Gore Excluder Conformable AAA Device June 8, 2016 The CE mark broadens the company’s menu of solutions for the endovascular treatment of aortic disease. Read More