DiFusion Technologies has received the US Food and Drug Administration's (FDA) approval for its Vestakeep Peek-based Xiphos ALIF (polyetheretherketone) spinal implant for use in Interbody Fusion (IBF) devices. Evonik's Vestakeep Peek is ...
The US Department of Agriculture's Food Safety and Inspection Service (FSIS) and the US Food and Drug Administration (FDA) have conducted a study to better understand the risks associated with certain foods prepared in retail delicatessens. ...
Tags: Food Safety, Food
Wrigley, a US-based chewing gum manufacturer, has announced that it has temporarily supended the production, sales, and marketing of Alert Energy caffeine gum over safety concerns. The company's decision comes after a series of ...
Tags: Wrigley, Caffeinated Gum
Cubist Pharmaceuticals has received the US Food and Drug Administration (FDA) fast track status for its late-stage antibiotic candidate ceftolozane/tazobactam in the previously granted Qualified Infectious Disease Product (QIDP) ...
Tags: Cubist, Fast Track Status
The US Food and Drug Administration (FDA) has warned the people that the anti-seizure drug, Potiga, developed by Valeant Pharmaceuticals and co-marketed with GlaxoSmithKline, may cause eye and skin problems. FDA warned that Potiga may ...
Tags: Anti-Seizure Drug Potiga, Medicine
Abbott has received CE Mark for its Architect clinical chemistry Hemoglobin A1c (HbA1c) test, which may assist physicians in diagnosing and monitoring diabetes as well as identifying patients at risk for developing diabetes. The HbA1c ...
The US Food and Drug Administration (FDA) has approved Biolase's WaterLase iPlus all-tissue laser for soft-tissue procedures in orthopedic and podiatric surgery as a surgical instrument. The iPlus has been cleared for incision, excision, ...
Tags: Podiatric Surgeries, Medicine
US-based Life Spine has received 510(k) marketing clearance from the US Food and Drug Administration (FDA) for its IRIS Anterior Cervical Plate System (ACPS). The IRIS ACPS comprises a low profile plate with a zero-step integrated nitinol ...
Tags: Life Spine, Plate System
The US Food and Drug Administration (FDA) has accorded its approval for a new Gibralt Occipital Spine System, developed by the US-based Exactech. The clearance is expected to allow the company to proceed with its plans to make initial ...
Tags: Spine System, Medicine
Ethicon Endo-Surgery's division Sedasys has received premarket approval (PMA) from the US Food and Drug Administration (FDA) for the first computer-assisted personalized sedation (CAPS) solution, Sedasys System. The system is used for the ...
Tags: Ethicon, Premarket Approval
The US Food and Drug Administration (FDA) has granted orphan drug exclusivity to Hyperion's Ravicti (glycerol phenylbutyrate) liquid. Hyperion Therapeutics president and CEO Donald Santel said that the orphan drug exclusivity further ...
Tags: Hyperion, Ravicti Liquid
Superstorm Sandy devastated not just homes and property, but people's ability to get needed health care, too. A quarter of the people in our survey of online subscribers in Connecticut, New Jersey, and New York said Sandy caused medical ...
Navidea Biopharmaceuticals has launched its Lymphoseek (technetium Tc 99m tilmanocept) Injection in the US. The injection is used in lymphatic mapping procedures that help in the diagnostic evaluation of potential cancer spread for ...
Tags: Navidea, Lymphoseek
The US Food and Drug Administration (FDA) has approved Raptor's Procysbi (cysteamine bitartrate) delayed release capsules for the treatment of nephropathic cystinosis in adults and children six years and older. Studies have shown that ...
Tags: Capsules, Raptor's Procysbi
US-based nutraceutical company Xymogen has announced the recall of artriphen, a product recommended for the support of healthy joint function, as it contains traces of the allergens soy and milk, which were not included in the product's ...
Tags: Xymogen, Artriphen Product, Labeling Issue