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
True Diagnostics has gained CE-mark approval to distribute its TrueDX platform and quantitative thyroid-stimulating hormone (TSH) test in Europe. The TrueDX platform helps physicians to determine whether a patient suffers from a ...
Tags: TrueDX platform, thyroid-stimulating hormone test, TSH test
Accuray has received 510(k) clearance for its new CyberKnife M6 Series from the US Food and Drug Administration (FDA). Designed for use in stereotactic radiosurgery (SRS) and stereotactic body radiation therapy (SBRT) treatments, the ...
Tags: FDA, stereotactic radiosurgery, stereotactic body radiation therapy
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Semprus BioSciences' vascular access catheter, designed to provide peripheral access to the central venous system. Using Semprus Sustain technology, the ...
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
GenMark Diagnostics has received 510(k) clearance from the US Food and Drug Administration (FDA) for its eSensor Respiratory Virus Panel(RVP) for use on its XT-8 system. The eSensorRVP test simultaneously detects and differentiates 14 ...
Tags: XT-8 system, FDA, clinical technology, clinical research
The US Food and Drug Administration(FDA)has granted 510(k)clearance to Ivera Medical's Curos Tips passive disinfection device which covers and protects the male luer connectors. Used in the administration of intravenous(IV)medication ...
Tags: FDA, male luer connectors, IV, Curos Tips
The US Food and Drug Administration(FDA)has granted 510(k)clearance to AtCor Medical's new blood pressure cuff-based system,designed for measuring brachial and central aortic blood pressure simultaneously. Available in ...
The US Food and Drug Administration (FDA) has accepted GeNO's filing of new drug application (NDA) for GeNOsyl MVG-2000 nitric oxide delivery system. GeNOsyl nitric oxide is a vasodilator which is indicated for the treatment of term and ...
Tags: GeNOsyl nitric oxide, FDA
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Masimo's new uSpO2 universal pulse oximetry cable for use with GE Healthcare's patient-worn monitors in ambulatory patient care environments. The uSpO2 cable is an ...
Tags: pulse oximetry cable, patient care environments, pulse oximetry device
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 ...
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Providence Medical Technology for its PMT Bone Screws, designed for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture ...
Tags: FDA, PMT Bone Screws, disposable instruments, disposable implants
Life Technologies Corporation's OpTmizer CTS T-Cell Expansion Tissue Culture Medium has received FDA 510(k) clearance as a Class II medical device to transit studies from the research bench to clinical trials. The OpTmizer CTS, as a ...
Tags: FDA, clinical technology, clinical trials
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 ...