Here’s a roundup of companies announcing clearances and approvals from the Food & Drug Administration and foreign regulatory agencies. Check out MassDevice’s compilation of the latest regulatory news for additional clearances and approvals.
- Thermo Fisher wins FDA clearance for kidney transplant rejection test
The Food & Drug Administration granted 510(k) clearance to a test made by Thermo Fisher Scientific Inc. (NYSE:TMO) to help manage potential organ rejection in kidney transplant patients. The test, called "QMS Everolimus Immunoassay," monitors the blood level of everolimus, a drug that helps prevent rejection in kidney transplants. It is the first FDA-cleared test physicians can use to maintain appropriate levels of the immunosuppressant everolimus. The drug, marketed under the trade name Zortress, was approved by FDA in April 2010 for use in adult kidney transplant patients who are at low-to-moderate immunologic risk. Zortress is marketed by East Hanover, N.J.-based Novartis (NYSE:NVS).
- Venous Health lands FDA clearance for fully portable pneumatic compression system to treat vascular insufficiency
Venous Health Systems Inc. a developer of solutions for treating vascular insufficiency by enhancing blood circulation, received 510(k) clearance from the FDA to market the Vasculaire Compression System. The device is a portable pneumatic device for treating vascular insufficiency. It features an innovative platform technology comprised of a fully-portable pneumatic controller attached to a patented multi-cell compression sleeve. When the compression sleeve is placed on the patient’s calf and foot and the controller is activated, the cells promote circulation with a sequential rapid inflation wave-like motion.
- TomTec nets FDA clearance for 4D MV-Assessment 2.0 software
TomTec Imaging Systems GmbH announces the FDA 510(k) clearance for its new 4D MV-Assessment 2.0 product. The software uses real-time three-dimensional echocardiography (3DE) for the analysis of the mitral valve. Within less than a minute, 4D MV-Assessment© 2.0 derives static and dynamic measurements of the entire mitral valve apparatus. This solution is tailored to clinical setups where precise diagnosis meets the demand of topmost efficiency. Automated features and a “smart workflow” have considerably shortened analysis times and supply users with accurate information for their clinical decision in seconds.
- Oculus receives FDA clearance for Microcyn-based dermatology hydroGel
Oculus Innovative Sciences Inc. (NSDQ:OCLS), a commercial healthcare company that designs, produces and markets safe and effective tissue care products based upon the Microcyn Technology platform, announced it had received a new FDA 510(k) clearance for its uniquely formulated Microcyn-based Epicyn HydroGel. Under the supervision of a healthcare professional, it is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including atopic dermatitis and radiation dermatitis. Epicyn HydroGel may also be used to relieve the pain of first- and second-degree burns and can help to relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process. The hydrogel is a shelf-stable hypochlorous acid formulation based on the company’s proprietary Microcyn Technology platform.
- Covidien to launch TurboHawk plaque excision system for small vessels
Covidien (NYSE:COV), a global provider of healthcare products, announced that it will launch the TurboHawk Plaque Excision System for small vessels next month in the U.S. and several international markets. The new system is intended to treat calcified and non-calcified lesion morphologies in small vessels, broadening minimally-invasive treatment options for Peripheral Arterial Disease (PAD). The device received 510(k) clearance from the FDA in January.