Target Health and LifeOnKey have own Israel-United States Binational Industrial Research and Development (BIRD) Foundation award to integrate the EMR with the electronic data capture (EDC) clinical trial database. The two-year award worth ...
Tags: Health, LifeOnKey, clinical trial
Invendo Medical, a developer of disposable endoscopy products, has installed its single-use colonoscope at two GI endoscopy centers including NYU Langone Medical Center and NewYork-Presbyterian Hospital/Columbia University Medical Center. ...
Tags: Invendo, colonoscope, Medical
Medical technology company Stryker has introduced the Universal SMARTLock Hybrid MMF system for the treatment of mandibular and maxillary fractures. Combining the strength and rigidity of arch bars with the safety and efficiency of MMF ...
Tags: Stryker, medical technology, SMARTLock Hybrid MMF system
Abbott has presented clinical study data from a Endovascular Valve Edge-to-Edge REpair STudy (EVEREST II ) High Surgical Risk cohort of its MitraClip System for the treatment of mitral regurgitation (MR). The CE-marked catheter-based ...
Tags: clinical study, MitraClip System, medical
Medtronic has submitted its investigational device exemption (IDE) application to the FDA to initiate a study of its Symplicity renal denervation system for the treatment of uncontrolled hypertension in patients with systolic blood pressure ...
What sits on the grocery shelf is often not what it seems — especially regarding olive oil, honey, fish and wine. The National Center for Food Protection and Defense estimates that Americans pay $10 billion to $15 billion annually for ...
Tags: Food Protection and Defense, food safety, US
The US Food and Drug Administration (FDA) has granted 510(k) approval to Vital Images' CT transcatheter aortic valve replacement (TAVR) planning application. TAVR procedures, in general, use endovascular techniques to replace faulty ...
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Nuvo Research's US licensing partner, Mallinckrodt, following the review of Mallinckrodt's New Drug Application (NDA) for diclofenac sodium topical ...
Boston ScientificBoston Scientific, a manufacturer of medical devices, is now offering Rubicon Support Catheter in 0.035" and 0.018" diameters in the US. The FDA-approved and CE-marked device, which provides various functionalities such ...
Tags: Boston Scientific, medical devices, Rubicon Support Catheter
CircuLite has obtained conditional approval from the US Food and Drug Administration (FDA) for its Synergy Circulatory Support System, designed for reversing the symptoms of heart failure in ambulatory chronic heart failure patients. The ...
Tags: CircuLite, FDA Conditional Approval, Micro-Blood Pump Device
The US Food and Drug Administration (FDA) has accepted to review Iroko Pharmaceuticals New Drug Application (NDA) for lower dose submicron diclofenac, a non-steroidal anti-inflammatory drug (NSAID), with a proposed indication of treatment ...
Tags: FDA, Pharmaceuticals, Medicine
The US Food and Drug Administration (FDA) has accepted for review AMAG Pharmaceuticals' supplemental new drug application (sNDA) for Feraheme (ferumoxytol) injection for Intravenous (IV) use. The sNDA filed is to expand the indication for ...
Tags: FDA, Pharmaceuticals, oral iron treatment
The US Food and Drug Administration (FDA) has accepted Biogen Idec's biologics license application (BLA) for the marketing approval of recombinant factor IX Fc fusion protein (rFIXFc) for the treatment of hemophilia B. Using the company's ...
Tags: FDA, Idec BLA, hemophilia B
The US Food and Drug Administration (FDA) has approved Tenaxis Medical's ArterX Surgical Sealant, designed for use in vasculature reconstruction in various surgical procedures. ArterX Surgical Sealant is a two-part liquid system that will ...
Health Canada has granted approval to OrthoAccel Technologies to distribute AcceleDent into the Canadian market. The FDA-approved AcceleDent is a clinical approach that applies gentle micropulses, SoftPulse Technology, to safely ...
Tags: OrthoAccel, FDA, clinical approach