Devices

New BD COR Molecular Diagnostic Platform Cleared

FDA has cleared a BD (Becton, Dickinson) 510(k) for its new automated, high-throughput infectious disease molecular diagnostics platform. The first test available on the new BD COR system is the BD CTGCTV2 molecular assay, a single test that detects the three most prevalent non-viral sexually transmitted infections — Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis.

The device eliminates the need to sort specimens, freeing up time for other lab processes, according to the company. It allows 1,700 specimens to be loaded, with onboard capacity for reagents and samples that provide more than seven hours of unimpeded system processing. The system can deliver up to 1,000 sample results in 24 hours, eliminating multiple manual interactions per shift that were traditionally required, Medtronic says.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome