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
Additive Orthopaedics’ 3D Printed Implant Secures FDA Clearance June 2, 2016 The agency cleared the company’s 3D printed titanium digital fusion implant. Read More
Occlutech Gains CE Mark for LAA Occluder June 2, 2016 The implant is designed for the closure of the LAA. Read More
FDA Approves Roche’s EGFR Mutation Test June 2, 2016 The test is intended to accompany lung cancer therapy Tarceva. Read More
Chinese FDA Approves Tissuemed’s TissuePatch June 1, 2016 The company says TissuePatch is the first synthetic sealant to nab CFDA approval. Read More
Luminex Nabs CE-IVD Mark for ARIES Flu A/B & RSV Assay June 1, 2016 The test is designed for use on the company’s ARIES System. Read More
BioVentrix Secures FDA IDE Approval to Begin Clinical Trial June 1, 2016 The trial involves 120 patients at up to 20 sites nationwide. Read More