Medical imaging technology company Toshiba America Medical Systems has announced that it will launch its Aquilion large bore CT system at American Society of Radiation Oncology annual meeting in Atlanta. The US Food and Drug ...
The US Food and Drug Administration (FDA) has finalized a new rule for the unique device identification (UDI) system, designed to provide a consistent and clear way to identify medical devices. The FDA worked jointly with industry, ...
Tags: Unique Device, Medicine
US-based Sapheon has submitted the first module of pre-market approval (PMA) application to the US Food and Drug Administration (FDA) for its VenaSeal sapheon closure system, designed to treat venous reflux (varicose veins) disease. This ...
Tags: PMA Application, Medicine
The US Food and Drug Administration’s (FDA) Ophthalmic Devices Panel announced that Ocular Therapeutix’s ReSure sealant is safe and effective in managing clear corneal wound leaks following cataract surgery. ReSure Sealant is ...
Tags: Ocular Therapeutix, Medicine
Greiner Packaging International has outlined plans to ban the use of chemical compound Bisphenol A (BPA) in the production of food packaging by the end of March 2014. The company plans to change all production lines to 'BPA-free' raw ...
Tags: Food Packaging, Food
Eliminating areas in process systems which may increase the potential for bacteria growth, such as traps and crevices, is an important requirement for control valves used in aseptic applications. Samson Controls offer a range of products ...
Tags: Valves, Manufacturing, Processing Machinery
A multiple-sclerosis drug that was at the center of Sanofi SA's SAN.FR +1.12% $20 billion takeover battle for Genzyme Corp. three years ago was approved for sale in Europe on Tuesday, the drug's first regulatory approval world-wide. The ...
The US Food and Drug Administration (FDA) has accepted to review AstraZeneca's new drug application (NDA) for Epanova, an investigational compound for the treatment for patients with severe hypertriglyceridaemia. Omthera Pharmaceuticals, ...
Global clinical technology solutions provider Trifecta Clinical and SAFE-BioPharma have entered into a strategic partnership to promote use of standards-based digital identities. Under the deal, Trifecta will implement SAFE-BioPharma's ...
US-based Crosstrees Medical has obtained 510(k) approval from the US Food and Drug Administration (FDA) for the Crosstrees PVA pod system for percutaneous vertebral augmentation (PVA). The FDA approval for the CE marked Crosstrees PVA pod ...
PolyNovo Biomaterials, a wholly-owned subsidiary of Calzanda, has filed 510(k) application with the US Food and Drug Administration (FDA) for an approval to market its NovoSorb wound dressing in topical negative pressure (TNP) wound ...
Quidel has obtained the US Food and Drug Administration (FDA) approval for two infectious disease tests that run on Life Technologies' QuantStudioDx instrument. Life Technologies' QuantStudioDx instrument offers the advanced capabilities ...
Tags: Diagnostic Tests, Quidel
US-based medical device company Neuros Medical has obtained an investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) for its Altius, an implantable generator that delivers high frequency Electrical ...
Tags: Implantable Generator, Medicine
Vital Access, a manufacturer of surgical and interventional technologies, has secured the US Food and Drug Administration (FDA) market approval for its VWING device, a vascular needle guide developed to enable vascular access to ...
Tags: Vital Access, VWING device
US-based orthopedics services provider Dallen Medical has filed 510(k) application with the US Food and Drug Administration (FDA) for individually packaged, sterile Compressyn staple implants. The Compressyn staple implant delivers ...
Tags: Compressyn Staple Implant, Health, Medicine