FDA Awards Marketing Clearance to Eko’s Heart Monitor June 7, 2017 The Duo is a handheld screening tool. Read More
FDA Clears Gore’s Preperitoneal Biomaterial Hernia Repair Device June 7, 2017 The kit includes three layers. Read More
3M’S Tegaderm CHG I.V. Gets FDA Clearance for Expanded Indication of Securement Dressing June 6, 2017 The dressing is a translucent gel pad. Read More
OrbusNeich Gains FDA Clearance for Coronary Dilatation Catheters June 6, 2017 The devices allow entry through tight lesions. Read More
Boston Scientific Wins CE Mark for the Vercise Primary Cell Deep Brain Stimulation System June 6, 2017 The device provides DBS therapy. Read More
FDA Approves Expanded Indication for Sapien 3 Artificial Heart Valve for High-Risk Patients June 6, 2017 The valve-in-valve procedure offers an alternative to repeat surgery. Read More
Claret Medical Gains FDA Clearance for Its Sentinel Cerebral Protection System June 5, 2017 The Sentinel is positioned away from the aortic arch. Read More
Medovex Wins CE Mark for DenerveX System June 5, 2017 The system removes capsular tissue from the facet joint. Read More
Cardiac Troponin Test Receives CE Mark June 2, 2017 The Singulex Sgx Clarity cTnl assay measures the biomarker troponin. Read More
FDA Clears Roche’s Companion Diagnostic to Identify ALK-Positive Non-Small Cell Lung Cancer June 2, 2017 The assay is intended for in vitro diagnostic use. Read More
BioMérieux Wins FDA Clearance for BioFire’s FilmArray Respiratory Panel 2 June 1, 2017 The FilmArray RP2 advances the existing FilmArray respiratory panel by reducing the assay time. Read More
OrthoAccel's AcceleDent Optima Gains FDA Clearance June 1, 2017 The orthodontic device directly connects patients and practices with usage monitoring. Read More