Devices

EUA for Abbott BinaxNOW Covid Antigen Test

FDA has granted an emergency use authorization (EUA) for the Abbott BinaxNOW Covid-19 Ag Card, described as a fast, $5, 15-minute, easy-to-use Covid-19 antigen test. The company says it is offering a no-charge complementary phone app that allows people to display their BinaxNOW test results when asked by organizations where people gather, such as workplaces and schools.

Abbott says it will ship tens of millions of tests in September and ramp-up to 50 million tests a month in October.

It says that in clinical study data submitted to FDA, BinaxNOW demonstrated sensitivity of 97.1% (positive percent agreement) and specificity of 98.5% (negative percent agreement) in patients suspected of Covid-19 by their healthcare provider within the first seven days of symptom onset.

Under terms of the EUA, the test is for use by healthcare professionals and can be used in point-of-care settings that are qualified to have the test performed and are operating under a Clinical Laboratory Improvement Amendments (CLIA) certificate of waiver, certificate of compliance, or certificate of accreditation.

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