Devices

Thermo Fisher Gets 2 EUAs for Covid Tests

FDA has granted Thermo Fisher Scientific emergency use authorizations for the TaqPath Covid-19 Fast PCR Combo Kit 2.0 and the TaqPath Covid-19 RNase P Combo Kit 2.0, assays designed with increased target redundancy to compensate for current mutations and emerging SARS-CoV-2 variants. “Both PCR-based kits leverage an updated design from the original TaqPath assays, targeting eight different genes across three regions of the virus that causes Covid-19,” the company says. “This built-in redundancy helps ensure accuracy of results in situations where gene expression in the virus vary as new mutations emerge.”

Thermo Fisher says the TaqPath Fast PCR Combo Kit 2.0 assesses raw saliva and uses a simple workflow from sample collection direct to PCR to help preserve supplies. Results are returned in about two hours. The TaqPath RNase P Combo Kit 2.0 is designed with an approximate three-hour turnaround time and can detect SARS-CoV-2 from individuals suspected of Covid-19 as well as from patients who are asymptomatic.

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

Read more

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