Medical gadgets News

Nanosphere Verigene SP Respiratory Virus Panel Categorized as Moderate Complexity by FDA

Nanosphere, Inc., received notification from the U.S. Food and Drug Administration (FDA) that its respiratory virus panel (RVNATSP) performed on the Verigene SP System has been categorized as “Moderate Complexity” under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The “Moderate Complexity” designation allows the test to be run in more settings by a broader [...]



Catheter-Based Device for Mitral Valve Repair from Abbott

Late-breaking data presented today at the American College of Cardiology’s 59th annual scientific session from the landmark EVEREST II (Endovascular Valve Edge-to-Edge REpair STudy) trial demonstrated that Abbott’s investigational MitraClip® system met both its primary safety and effectiveness endpoints(1), suggesting that the minimally invasive MitraClip procedure may be an important treatment option for patients with [...]