The US Food and Drug Administration (FDA) has cleared X-spine's new spinal systems to treat various spinal pathologies. The products including Fortex CoCr Rod system incorporates a new cobalt chromium fixation rod, designed to provide ...
Tags: FDA, spinal systems, Fortex CoCr Rod system
GI Dynamics has gained full approval to initiate ENDO trial for its non-surgical EndoBarrier device from the US Food and Drug Administration (FDA). The EndoBarrier liner, which is implanted into the gut, is a flexible, tube-shaped device ...
Tags: ENDO trial, non-surgical EndoBarrier device, EndoBarrier liner
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Providence Medical Technology for its PMT Bone Screws, designed for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture ...
Tags: FDA, PMT Bone Screws, disposable instruments, disposable implants
US-based provider of machine-readable anti-counterfeiting solutions InkSure Technologies has launched high security taggants which have been approved by the US Food and Drug Administration(FDA)for direct food contact. The taggants,which ...
Tags: FDA, high security taggants, anti-counterfeiting product line
The US Food and Drug Administration (FDA) has accepted to review Ferring Pharmaceuticals' new drug application (NDA) of controlled release misoprostol vaginal insert (MVI) for decreasing time to vaginal delivery in women with an unfavorable ...
The US Food and Drug Administration (FDA) has approved Eisai's non-competitive AMPA glutamate receptor antagonist for patients who continue to have seizures despite being on other prescription medications for epilepsy. The drug, ...
The US Food and Drug Administration's (FDA) Center For Drug Evaluation and Research has issued new guidelines for the packaging of test batches manufactured for Abbreviated New Drug Applications (ANDA), Abbreviated Antibiotic Applications ...
Tags: FDA, food, drug, packaging, test batches, ANDA, labeling
India-based Lupin's subsidiary Lupin Pharmaceuticals has received final approval for Kurvelo tablets from the US Food and Drugs Administration (FDA) to market a generic version of Teva Nordette tablets. The tablet, which is the AB-rated ...
US Food and Drug Administration (FDA) has approved an update to the labeling for Bristol-Myers Squibb's Baraclude to include data on African Americans and liver transplant recipients with chronic hepatitis B infection. The present ...
US-based Nina International is voluntarily recalling its Ground Hot Pepper due to possible Salmonella contamination, according to the US Food and Drug Administration (FDA). The recall was initiated after a routine sampling showed positive ...
Tags: FDA, Salmonella, Ground Hot Pepper
The US Food and Drug Administration (FDA) has cleared Baxano's new iO-Tome instrument, designed to remove the facet joint, which is commonly performed in spinal fusion applications. Utilizing iO-Flex technology, the iO-Tome instrument ...
Tags: iO-Tome instrument, spinal fusion instrument, MicroBlade Shaver
The US Food and Drug Administration (FDA) has granted clearance to Fenwal for two new indications for collection of plasma products on its cell separation devices, thus providing blood centers more flexibility to collect plasma on mobile ...
Tags: cell separation devices, collection of plasma products, plasma products
Whole Foods Market is voluntarily recalling its kitchen soup,which is labeled as Roasted Garlic and Eggplant Soup but contains Lobster Bisque,according to the US Food and Drug Administration(FDA). The product being recalled was sold in ...
Tags: FDA, kitchen soup, life threatening reaction, labeling error
Kraft Foods has said it is"on track"to complete its three-year initiative to reduce salt in its North American portfolio by an average of 10%. The company said yesterday(26 September)it has already cut salt by 10%in products such as Oscar ...
Tags: Kraft Foods, three-year initiative, salt, cheese
LED-based sequencer to track Salmonella and E.coli 18 Sep 2012 US Food&Drug Administration agrees$17??million contract for sequencing systems to track future outbreaks of potentially harmful pathogens. Illumina,the San Diego company ...
Tags: the San Diego company, LED, Salmonella, E.Coli, MiSeq systems