GenMark Diagnostics has obtained the US Food and Drug Administration's (FDA) 510(k) clearance for its eSensor Respiratory Virus Panel, designed for use on its XT-8 system. The test is intended to simultaneously detect and differentiate 14 ...
Tags: GenMark, FDA clearance, eSensor Respiratory Virus Panel, XT-8 system
Tangent Medical has gained FDA 510(k) clearance for the NovaCath Secure IV Catheter System designed to address peripheral IV challenges including catheter stabilization, healthcare worker safety, tubing management and patient comfort. ...
Tags: FDA, Catheter System, medical device, clinical technology
Precision Spine, the parent company of Spinal USA, has announced FDA 510(k) clearance of the Slimplicity solo anterior cervical plate system. The Spinal USA's Slimplicity new anterior cervical plate system, which consists of one and two ...
Tags: Spinal USA, FDA 510(k)clearance, solo anterior cervical plate system
Mevion Medical Systems, a radiation therapy company, has received FDA 510(k) clearance for its MEVION S250 Proton Therapy System. The MEVION S250, powered by a patented TriNiobium Core, provides the delivers precise and intense proton ...
Tags: Mevion Medical, FDA 510(k)clearance, MEVION S250, Proton Therapy System
Quest Diagnostics has received FDA 510(k) clearance for its Simplexa C difficile Universal Direct Test on the 3M Integrated Cycler. The test, which uses a proprietary chemistry that eliminates the need for nucleic-acid extraction, is ...
Tags: Quest Diagnostics, 3M integrated cycler, Simplexa tests
Quidel has received FDA 510(k) clearance for its Quidel Molecular Influenza A+B assay for the detection of influenza A and B for use with Cepheid's SmartCycler PCR system. Quidel received FDA clearance in December 2011 to run its Quidel ...
Tags: Quidel, FDA 510(k)clearance, Quidel Molecular Influenza A+B assay
Sotera Wireless has won FDA 510(k) clearance for its full ViSi Mobile System and is commencing sales to hospitals nationwide. The ViSi Mobile System, which consists of a small device and non-invasive sensors for freedom of movement, is ...
Abiomed, medical device company, has won FDA 510(k) clearance for new, high flow percutaneous, catheter-based Impella device with peak flows of approximately four liters of blood per minute. The new percutaneous heart pump, which is ...
Tags: Abiomed, Impella Cardiac Power, Impella cVAD
Covidien has won FDA 510(k) clearance for the iDrive Ultra powered stapling system, a reusable, battery-operated endoscopic surgical stapler. The iDrive Ultra system leverages proprietary Tri-Staple technology that provides less stress on ...