Devices

Covid/Flu Rapid Test Authorized for OTC Use

FDA has granted a de novo marketing authorization to Healgen for its over-the-counter Healgen Rapid Check Covid-19/Flu A&B Antigen Test. The test, which is intended for use by individuals experiencing respiratory symptoms, uses a nasal swab sample to deliver at-home results in about 15 minutes, according to an FDA news release. It detects proteins from both SARS-CoV-2 and influenza A and B, it says.

The authorization was based on data from a study of individuals with signs and symptoms of Covid-19 and influenza, “which showed that this test correctly identified 99% of negative and 92% of positive SARS-CoV-2 samples, 99.9% of negative Flu A and B samples, and 92.5% and 90.5% of positive Flu A and Flu B samples, respectively,” FDA says. “As with all rapid antigen tests, which generally have lower sensitivity than molecular tests, there is a risk of false negative test results. Individuals who test negative and continue to experience symptoms of fever, cough and/or shortness of breath may still have SARS-CoV-2, flu or another respiratory infection and should seek follow up care with their health care provider."

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