The US Food and Drug Administration (FDA) has approved Alere's pre-market application (PMA) for the commercialization of Alere Determine HIV 1/2 Ag/Ab Combo in the country. The FDA approval allows the marketing of Alere Determine HIV 1/2 ...
Tags: Alere Determine, Medicine
Verizon, a US- based broadband and telecommunications company, has received the US Food and Drug Administration (FDA) 510(k) clearance for a cloud-based, remote patient-monitoring medical device called Converged Health Management. ...
Tags: Verizon, Patient-Monitoring Device
The US Food and Drug Administration (FDA) has approved the first rapid point-of-care test that detects both HIV-1/2 antibodies and the HIV-1 antigen in human serum, plasma, and venous or fingerstick whole blood specimens. The Alere ...
Tags: Rapid Diagnostic Test, HIV-1, HIV-2
Hansen Medical has enrolled first patients for ARTISAN-AF clinical trial to evaluate the use of Artisan family of control catheters with its Sensei X robotic catheter system for treatment of atrial fibrillation. The robotic catheter ...
Tags: Hansen Medical, Clinical Trial
Quidel, a US-based virology assays and molecular diagnostic systems provider, has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Sofia hCG fluorescent immunoassay for use on the Sofia Analyzer. It is used ...
Tags: FDA Clearance, HCG Fluorescent
The US Food and Drug Administration (FDA) Ophthalmic Devices Advisory Panel is scheduled to decide on Ocular Therapeutix’s premarket approval application for the ReSure Sealant in September and may suggest some recommendations. ...
Tags: Ophthalmic Devices, Health
LDR has received a letter of approval from the US Food and Drug Administration (FDA) for commercial sale and distribution of its Mobi-C Cervical Disc (Mobi-C), for one-level indications in the US. The Mobi-C is designed for cervical disc ...
Tags: Mobi-C Cervical Disc
US-based establishment Heeren Brothers Produce is recalling around 5,400 cantaloupes as they may have been contaminated with Listeria monocytogenes, according to the US Food and Drug Administration (FDA). The produce associated with the ...
Tags: Heeren Brothers, Cantaloupes
Betty Crocker, the brand owned by US food company General Mills, has launched a new line of Helper skillet dinners and Betty Crocker potatoes. The company noted that the new products complete the meal, making them the ultimate dinner ...
Tags: Betty Crocker, Ultimate Potatoes
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 ...
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
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 ...
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