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
Advanced Cooling Therapy Secures Expanded CE Mark May 25, 2016 The device is designed to control patient temperature using esophageal space. Read More
FDA Approves Roche’s Cytomegalovirus Test May 25, 2016 The CMV test is the first to nab FDA approval for use in hematopoietic stem cell transplant recipients. Read More
Interventional Spine Garners FDA Clearance May 24, 2016 The device alleviates pain by adjusting the pressure on the lower spine. Read More
Implanet Scores FDA Clearance, CE Mark May 24, 2016 The hybrid implant offers autostable posterior fixation. Read More
FDA Clears Perimeter Medical’s Optical Tissue Imaging System May 24, 2016 The system can visualize sub-surface structures up to 2 mm below the surface. Read More
Surgical Specialties’ BioSentry System Gains Expanded Label May 23, 2016 The system is indicated for use in percutaneous transthoracic lung biopsy procedures. Read More