Ortho Clinical Diagnostics has received CE mark approval for its new diagnostic blood test, Vitros Immunodiagnostic Product 25-OH Vitamin D Total assay. The Vitros 25-OH Vitamin D Total assay is an one-step immunoassay designed to use on ...
Tags: diagnostic blood test, Vitros Immunodiagnostic Product
Maquet Cardiopulmonary, a unit of Maquet Cardiovascular, has entered into an agreement to purchase Avalon Laboratories' Elite Bi-Caval Dual Lumen Catheter and complimentary vascular access kits for use during extracorporeal life support ...
Tags: Maquet, cardiopulmonary, ECLS
Initial public offering of stock by the loss-making TRIA Beauty postponed due to"ongoing global economic instability". TRIA Beauty,a Californian firm that specializes in hand-held laser diode systems for hair removal,acne treatment and ...
The US Food and Drug Administration (FDA) has granted 510(k) approval to Medigus's SRS endoscopic system. The approval was based on a multi-center clinical trial which met a criteria of safety and efficacy in five countries and three ...
Tags: SRS endoscopic system, endoscopic system, SRS endoscope, the SRS system
The US Food and Drug Administration (FDA) has approved Novartis Afinitor (everolimus) to treat patients with non-cancerous kidney tumors associated with tuberous sclerosis complex (TSC). The approval was based on the Phase III ...
EpiCept has received fast track designation for AmiKet (amitriptyline 4%, ketamine 2% cream) from the US Food and Drug Administration (FDA). AmiKet is indicated for the treatment of neuropathic pain associated with ...
Tags: FDA, fast track designation, treatment of neuropathic pain
The US Food and Drug Administration (FDA) has approved Novo Nordisk's Levemir (insulin detemir [rDNA origin] injection) for a pregnancy Category B classification. The approval indicates that Levemir, when used in pregnant women with ...
Tags: FDA approval, lable update, Levemir, clinical study