Devices

Eko Murmur Smart Stethoscope Software Cleared

FDA has cleared an Eko 510(k) for its Eko Murmur Analysis Software (EMAS) for detecting and characterizing murmurs found in adults and pediatric patients. The smart stethoscope can “identify and differentiate between innocent and structural heart murmurs indicative of valvular heart disease,” the company says.

Valvular heart disease is a life-threatening condition often first identified with a stethoscope, according to the company. “While early detection is critical, millions of patients are expected to be undiagnosed, with as much as 57% of clinically significant valvular heart disease missed,” it says. “By combining murmur analysis [artificial intelligence] AI with its digital stethoscopes, Eko has transformed the traditional stethoscope into an objective, low-cost, and scalable screening tool that can identify significant structural heart disease in seconds on the front lines of care.”

Eko says its data showed that among adults 18 years and older, the EMAS algorithm identified structural murmurs with a sensitivity of 90.2% and specificity of 90.6%. “When using traditional stethoscopes to detect significant valvular heart disease, general practitioners (GPs) were found to have a sensitivity of 44% and specificity of 69%,” it adds.

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