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
Respiratory Motion Gains CE Mark Approval for ExSpiron May 26, 2016 ExSpiron was introduced at the annual meeting of the Society of German Anesthesiologists last month. Read More
Ortho Kinematics Scoops Up Health Canada Approval May 26, 2016 The test is now licensed for sale in Canada, the U.S. and Europe. Read More
Mauna Kea Wins FDA Clearance for Confocal Miniprobes May 26, 2016 The device is designed for use in urological and minimally invasive surgical applications. Read More