Stryker Interventional Spine has received 510(k) clearances from the US Food and Drug Administration (FDA) for Venom RF cannula and electrode combination and11g iVAS balloon system. The Venom RF cannula and electrode combination contains ...
TYRX, a provider of implantable cardiac devices, has announced the first implantation of its new AIGISRx R fully resorbable antibacterial envelope at the Vanderbilt Heart and Vascular Institute in Nashville, Tennessee. The second ...
The US Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee has recommended approval of Bayer’s oral soluble guanylate cyclase (sGC) stimulator, riociguat, in two forms of pulmonary ...
Tags: FDA Advisory Committee
U.S. Senators Dick Durbin (D-IL) and Richard Blumenthal (D-CT) have introduced legislation that would help consumers distinguish between dietary supplements that are safe and those that have potentially serious side-effects or drug ...
Tags: Supplements Labels, Medicine, Packaging, Printing
The US Food and Drug Administration (FDA) has approved the supply of GlaxoSmithKline's four-strain (quadrivalent) influenza vaccine, Fluarix Quadrivalent, to CDC distribution centers and healthcare providers in the US. Fluarix ...
Quidel has won FDA 510(k) clearance for its Sofia hCG fluorescent immunoassay (FIA) for use on the Sofia Analyzer to detect elevated levels of human chorionic gonadotropin (hCG), an early indicator of pregnancy. The Sofia Analyzer and ...
Tags: Quidel, Fluorescent Immunoassay
The US Food and Drug Administration (FDA) has published a new regulation, under which products labeled gluten-free must contain less than 20 parts per million of gluten. The regulation has been issued in order to provide a uniform ...
Tags: Food Products, New Standard
The US Food and Drug Administration (FDA) has published a new regulation defining the term gluten-free for voluntary food labeling, in order to provide a uniform standard definition to help up to 3 million Americans who have celiac disease. ...
Tags: Gluten-Free Labelling
US-based establishment Purity First Health Products is voluntarily recalling Healthy Life Chemistry branded health supplements over safety concerns, according to the US Food and Drug Administration (FDA). The products subject to the ...
Tags: Purity First, Health Supplements
Lupin Pharmaceuticals has gained tentative FDA approvals for Armodafinil tablets, 50mg, 100mg, 150mg, 200mg and 250mg strengths in addition to Doxycycline capsules, 40mg (30mg immediate-release and 10mg delayed-release). Armodafinil ...
Pfizer’s Wyeth has consented to pay $491m in fine for unlawful marketing of its kidney drug Rapamune, an FDA-approved immunosuppressant drug used to prevent rejection in organ transplantation. In order to boost Rapamune sales, the ...
Tags: Pfizer Unit, Medicine
Perrigo Company has received final FDA approval for abbreviated new drug application for generic equivalent to cutivate lotion, 0.05% and begins immediate shipment of the product. Cutivate Lotion 0.05% (fluticasone propionate lotion, ...
The US Food and Drug Administration (FDA) has expanded age indication for Novartis' Menveo (Meningococcal [Groups A, C, Y and W-135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine) to include infants and toddlers aged two months and ...
Hologic has received the US Food and Drug Administration (FDA) clearance for its Single Energy (SE) femur exam, designed to visualize features associated with AFFs quickly and conveniently at the time of osteoporosis assessment. The quick ...
Tags: Hologic, FDA Clearance
NEC Display Solutions, a provider of commercial LCD display and projector solutions, has received the Food and Drug Administration 510(k) clearance for its 21-inch MultiSync MD211G5 medical-grade monitor. The LED-backlit IPS diagnostic ...