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
Cardium Therapeutics has filed a new 510(k) submission for its current FDA-cleared Excellagen advanced wound care product based on the company's supplemental research and development activities. The new 510(k) submission describes ...
Pharmaceutical and healthcare company GlaxoSmithKline (GSK) will roll out two-dimensional (2D) barcodes on the inner containers as well as outer boxes for most of its US vaccines. According to the company, a 2D barcode is a small square ...
Tags: GlaxoSmithKline, 2D Barcodes
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
IMRIS has obtained CE mark for its specialized multifunctional surgical theater called VISIUS iCT, designed for spinal and neurosurgical needs. Claimed to be the first ceiling-mounted intraoperative CT solution available in the market, ...
Tags: CE Mark, CT Solution
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
Island Abbey Foods, a Canadian producer of specialty food and natural health product, has launched Honibe Honey Delights candies and Honibe Pure Liquid Honey in Co-Op Atlantic stores. Honibe Honey Delights contain 100% pure honey and ...
Medtronic, a US-based developer of medical devices, has introduced its new implantable neurostimulation systems, also called spinal cord stimulation (SCS) systems, for use in the treatment of chronic, intractable back and limb pain that are ...
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
To address the demand for low-migration solutions, Flint Group introduced The announcement follows the launch of Novasens conventional sheetfed offset inks in 2010, with the new Ultraking 4500 LM PREMIUM and 4600 LM PLAS PREMIUM ...
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
India-based Torrent Pharma’s US subsidiary has announced the recall of the company’s anti-psychotic drug Olanzapine 10mg tablets from the US market due to a packaging issue. Torrent manufactured the drug for Prasco Labs in the ...
Tags: Torrent Pharma, Packaging Issue
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
Flint Group has launched the new Ultraking family of low-migration UV curable offset packaging inks for the North American market. The new Ultraking 4500 LM PREMIUM and 4600 LM PLAS PREMIUM low-extractable, low-odor and low-migration ...
Tags: Flint Group, Food Packaging
CorMatrix Cardiovascular, a US-based medical device manufacturer, has received three patents from the US Patent and Trademark Office for its biomaterial heart valve that is made from biomaterial called extracellular matrix (ECM). The ...
Tags: Matrix Heart Valve, CorMatrix