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
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 ...
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
Tissue repair company Regentis Biomaterials has reported positive results from a clinical safety study of hydrogel implant GelrinC, designed to treat articular cartilage in injured knees. The CE mark-approved GelrinC hydrogel implant is ...
Tags: Regentis Biomaterials, Medicine
Medtronic has unveiled new data from the Global SYMPLICITY Registry, a multi-centre, prospective, observational registry designed to collect comprehensive data evaluating procedural and long-term safety of the Symplicity renal denervation ...
Tags: Medtronic, Symplicity Registry
Biopharmaceutical firm Cubist Pharmaceuticals is voluntarily recalling four lots of Cubicin (daptomycin for injection) 500mg in 50ml single use vials in the US primarily due to presence of glass particulates. The company said that no ...
Tags: Cubicin Injection, Cubist
Canadian health products and medicines manufacturer Vita Health is recalling many of its Personnelle branded products over a labelling error. The recall is for certain lots of the company's Personnelle products including 'Cold and ...
Tags: health products, medicines
U.S. Senators Dick Durbin (D-IL) and Richard Blumenthal (D-CT) have introduced legislation that would help consumers distinguish between dietary supplements that are safe and those that have potentially serious side-effects or drug ...
Tags: Supplements Labels, Medicine, Packaging, Printing
Clinical-stage pharmaceutical company Adynxx has obtained the US Food and Drug Administration (FDA) fast track designation for its AYX1 injection, which is used for prevention of chronic pain. In a five-cohort, dose-escalating study ...
Clinical stage biopharma company Rexahn Pharmaceuticals has entered into an exclusive licensing agreement with the University of Maryland, Baltimore (UMB), for a novel drug delivery platform, which targets the delivery of chemotherapeutic ...
Tags: Rexahn Pharma, Oncology Drug
Micell, a US-based biomedical company, has received CE (Conformité Européenne) Mark clearance for its MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent SES). MiStent Sirolimus Eluting Absorbable ...
Tags: Micell, Mistent SES
US-based medical devices developer Elixir Medical has announced that the results of its CE Mark-approved DESyne BD Novolimus Eluting Coronary Stent System with biodegradable polymer coating were outstanding. Its CE Mark-approved DESyne BD ...
Direct Flow Medical, a developer of novel transcatheter heart valve technologies, has met its primary endpoint in the Discover CE Mark Trial by achieving 99% freedom from all-cause mortality at 30 days. The trial had enrolled 100 patients ...
Tags: Aortic Valve, Medicine
Medtronic has completed randomizing Symplicity HTN-3, a clinical trial of the Symplicity renal denervation system for treatment-resistant hypertension. Renal denervation is a minimally invasive, catheter-based procedure that decreases the ...
Tags: Medtronic, Randomizing Symplicity
CircuLite has received an approval from the Federal Agency for Medicines and Health Products to begin the CE Mark trial of the Synergy IC Circulatory Support System (SICSS), which is designed for interventional cardiologist cannula ...
Tags: Circulite, CE Mark Trial