Devices

FDA Clears AI Heart Failure Detector

FDA has cleared an Anumana 510(k) for ECG-AI LEF, an artificial intelligence (AI)-powered medical device to detect low ejection fraction (LEF) in patients at risk of heart failure. The device was developed in partnership with Mayo Clinic, and it screens for LEF using data from a routine 12-lead electrocardiogram (ECG), the company says. “Based on pioneering research from Mayo Clinic, the algorithm has been developed utilizing over 100,000 ECG and echocardiogram data pairs from unique patients and has been clinically tested in more than 25 studies involving more than 40,000 patients in the U.S. and internationally,” it adds.

Anumana says ECG-AI LEF was clinically validated in a multi-site, retrospective clinical study involving 16,000 racially diverse patients, “achieving its primary endpoint with an 84.5% sensitivity and 83.6% specificity.” Additionally, it says, a Mayo study called EAGLE, evaluated the use of an investigational version of the algorithm in routine clinical care of 22,641 adults by 120 primary care teams from 45 clinics or hospitals. That study demonstrated that ECG-AI LEF implementation “improved clinician’s ability to diagnosis of LEF by 31% versus standard of care without increasing the overall rate of echocardiogram usage,” it 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