GI Dynamics has obtained conditional approval from the US Food and Drug Administration (FDA) to initiate a pivotal clinical trial of its non-surgical EndoBarrier device. Flexible, tube-shaped EndoBarrier liner, which forms a physical ...
Tags: GI Dynamics, conditional approval, FDA, pivotal clinical trial
Guided Therapeutics has extended third consecutive year licensing agreement with Konica Minolta Technology Center to co-develop a non-invasive Barrett's Esophagus detection product. The Barrett's Esophagus product is based on the Guided ...
Tags: Guided, licensing agreement, Konica, co-develop
The US Food and Drug Administration (FDA) has granted 510(k) approval to Medtronic's Aquamantys3 BSC 9.1S bipolar sealer with cutting, designed for use in orthopaedic surgery. By utilizing Transcollation technology, the BSC 9.1S Bipolar ...
Tags: FDA, 510(k)approval, orthopaedic surgery, transcollation technology
Idaho Technology, a provider of instruments for pathogen identification and DNA analysis, has initiated clinical trial of its FilmArray blood culture identification (BCID) panel. The FilmArray BCID panel, which will run on the company's ...
Tags: Idaho, BCID panel, pathogen detection system
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Biosign Technologies' non-invasive blood pressure measurement system, Pulsewave monitor. The UFIT EN-10 monitor is worn on the wrist having 13.5 cm to 23 cm (5.3 ...
Tags: FDA, blood pressure measurement system, pulsewave monitor, systolic
S&P of California is recalling 1800 jars of its Su-nun Crush Roasted Thai Red Pepper due to possible Salmonella contamination, according to the US Food and Drug Administration (FDA). The recall was initiated after a routine sampling by ...
Tags: salmonella contamination, routine sampling, weakened immune systems
Cutting Edge Concessions is recalling Shake'Ems seasoning cups in the US, as the products contain milk as well as red 40 food color, which is not declared on the label. People who have an allergy or severe sensitivity to milk can ...
Tags: not declared on the label, allergy or severe sensitivity to milk
LDR has secured an approval letter from the US Food and Drug Administration (FDA) for its low-profile cervical intervertebral disc. The Mobi-C disc, which is a metal and polyethylene mobile bearing prosthesis, is a cervical implant ...
Tags: LDR, FDA, approval letter, cervical intervertebral disc, Mobi-C disc
Mylan has been sued jointly by Pfizer,Wyeth Pharmaceutical,Wyeth LLC and PF Prism regarding the filing of an abbreviated new drug application (ANDA) with the US food and drug administration (FDA) for desvenlafaxine succinate ...
Tags: Mylan, desvenlafaxine succinate extended-release tablets, MDD
The US Food and Drug Administration (FDA) has granted de novo petition to market Nanosphere's gram-positive blood culture nucleic acid test (BC-GP) on the automated sample-to-result Verigene system. Single automated BC-GP test detects ...
Tags: Nanosphere, FDA, BC-GP test, Verigene system
Roche Group member, Genentech has received US Food and Drug Administration (FDA) official approval of priority review designation for trastuzumab emtansine Biologics License Application (BLA). Trastuzumab Emtansine is designed to treat ...
The US Food and Drug Administration (FDA) has accepted Avanir Pharmaceuticals' investigational new drug (IND) application for the study of AVP-923, an investigational drug for the treatment of agitation in patients with Alzheimer's disease. ...
Tags: AVP-923, Alzheimer's disease, IND
The US Food and Drug Administration (FDA) has granted 510(K) approval to KFx Medical's AppianFx Tissue Fixation Anchor. The 5mm AppianFx Tissue Fixation Anchor is designed to reattach tissue to bone in foot and ankle procedures. Seaview ...
Tags: FDA, 510(K)approval, KFx Medical's AppianFx Anchor, implants
LDR has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its Avenue L Lateral Lumber Cage system, which is implanted via a direct lateral trans-psoatic approach for lateral lumbar fusion. Avenue Lumber Cage ...
Tags: LDR, 510(k)approval, FDA, Avenue Lumber Cage system, lateral lumbar fusion
Multinational biopharmaceutical company Celgene has received US Food and Drug Administration (FDA) approval for Abraxane, which is aimed to treat locally advanced or metastatic non-small cell lung cancer in combination with carboplatin in ...
Tags: Abraxane, lung cancer, Multinational biopharmaceutical company Celgene