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
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
Micro Interventional Devices Snags CE Mark June 7, 2016 The Permaseal device is designed for instant access to the left-ventricle. Read More
FDA Clears Cerêve’s Sleep System June 6, 2016 The device is specifically designed to reduce latency to stage 1 and stage 2 sleep. Read More
Axonics Nabs CE Mark for Sacral Neuromodulation System June 6, 2016 The system is designed for the treatment of urinary and fecal dysfunction. Read More
Noxilizer Wins FDA Clearance for NO2-based Sterilization of Medical Device June 3, 2016 Nitrogen dioxide gas sterilization functions with or without vacuum and humidity. Read More
Esco Medical Gains FDA Clearance for Miri TL IVF Incubator June 3, 2016 The incubator features a built-in microscope and camera. Read More
First Ray Wins FDA Clearance for SpeedButton System June 2, 2016 The system uses a transosseous fixation method. Read More
Avenu Medical Scoops Up CE Mark Approval June 2, 2016 The company also nabs IDE clearance for the device. Read More