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
FDA Approves Blue Earth Diagnostics’ Axumin Injection June 1, 2016 Axumin is the first product commercialized by Blue Earth Diagnostics. Read More
FDA Adcomm Gives Thumbs Up to St. Jude’s Amplatzer May 27, 2016 An FDA advisory committee recommends approval for St. Jude’s Amplatzer. Read More
SuperSonic Imagine Gains Japanese Clearance for Aixplorer May 27, 2016 The approval includes the company’s Planewave UltraSensitive imaging program. Read More