Tensys Medical's new continuous, non-invasive hemodynamic patient monitoring system has obtained 510(k) clearance from the US Food and Drug Administration (FDA). The TL-300 system, a member of T-Line family, is designed for use in ...
Tags: Hemodynamic Patient Monitor, FDA Approval, TL-300 system
Halt Medical has obtained $15m finance from American Capital to support the commercialization of its Acessa system, designed for treating uterine fibroids. Using a slender Handpiece, the CE-marked system delivers radiofrequency energy to ...
Tags: Halt Medical, American Capital, commercialization, Acessa system
Aegerion Pharmaceuticals' Juxtapid (lomitapide) capsules has received US FDA approval to be used as an adjunct to a low-fat diet and other lipid-lowering treatments. Juxtapid, which is a supplement to fat reduction treatments also ...
Tags: Juxtapid, US, FDA, capsules, treatments
Sunland’s peanut butter plant in New Mexico, which has been linked to a salmonella outbreak in the US, has received a FDA approval to recommence operations at the plant. The plant can re-operate after developing a sanitation plan ...
Tags: peanut butter plant, peanut butter, Sunland, FDA
The US FDA has approved the use of Genentech's Tamiflu (oseltamivir phosphate) for the treatment of Influenza in infants aged two weeks and more. Tamiflu works by blocking the ability of the virus to replicate in the body thereby ...
The US FDA has approved Chembio Diagnostics' Dual Path Platform (DPP) point-of-care HIV 1/2 rapid test. The DPP HIV 1/2 assay is developed to detect HIV-1/2 antibodies in either oral fluid or blood samples, which will bind directly with ...
Tags: FDA, HIV, oral fluid, detection reagents
Dendreon Corporation has sold its immunotherapy manufacturing facility (IMF) in Morris Plains, New Jersey, US, to Novartis Pharmaceuticals for $43m. In early 2012, Dendreon had decided to bring down Provenge production at the facility as ...
Tags: Novartis, Dendreon immunotherapy, manufacturing facility, Medicine
The US Food and Drug Administration (FDA) has granted regulatory approval to Avinger's Ocelot | PIXL. Ocelot | PIXL, which is supported by the company's Lightbox console, enables physicians to navigate lesions with a choice between 135cm ...
Aurobindo Pharma has won the final FDA approval to manufacture and market its generic anti-Human Immunodeficiency Virus (HIV) drug, Abacavir Tablets USP 300mg. Abacavir, the generic version of ViiV Healthcare Company's Ziagen Tablets ...
Tags: Anti-HIV Drug, FDA Nod, Aurobindo, Medicine
GlaxoSmithKline (GSK) has announced the FDA approval of four-strain seasonal influenza (flu) virus vaccine, Fluarix Quadrivalent, to immunize adults and children of three years age and more, in the US. The intramuscular vaccine is ...
GlaxoSmithKline (GSK) has announced FDA approval of raxibacumab anti-toxin as a combination therapy along with antibacterial drugs for the treatment of inhalational anthrax in both adult and pediatric patients with limited treatment ...
Syneron Medical has received the US Food and Drug Administration (FDA) approval for its new elos Plus multi-platform device. The new elos Plus device utilizes the company's proprietary elos technology of optical energy and bi-polar ...
Tags: FDA, elos Plus multi-platform device, medical technology
The US Food and Drug Administration (FDA) has cleared Respiratory Motion's ExSpiron respiratory monitoring system, designed for monitoring breathing abnormalities often associated with potentially lethal respiratory depression. ...
Tags: FDA, respiratory monitoring system, clinical technology
Sunshine Heart is planning to initiate a US pivotal trial on its C-Pulse Heart Assist device in the fourth quarter of 2012, as it received an unconditional approval from the US Food Drug Administration (FDA). The CE marked system, ...
Tags: FDA, clinical trial, medical system
Philosys is looking forward for the US Food and Drug Administration (FDA) approval of its new Gmate blood glucose monitoring system in third quarter 2012. By utilizing Smartphone technology, Gmate blood glucose meter works with the ...
Tags: Philosys, FDA approval, blood glucose monitoring system