Devices

FDA Clears Ultromics EchoGo Amyloidosis Device

FDA has cleared an Ultromics 510(k) for the EchoGo Amyloidosis, an artificial intelligence-based echocardiography device to assist with early detection of cardiac amyloidosis. The company says this is the first device to reach the market under CDRH’s Total Product Lifecycle Advisory Program. “The device was among 15 breakthrough cardiovascular devices to participate in the initial pilot launch phase of the FDA Total Product Lifecycle Advisory Program (TAP) which has since expanded with 55 companies currently enrolled,” it says.

The device requires a “single routinely acquired echocardiographic clip” to detect the disease, according to the company. “The ability to automatically detect and flag potential cardiac amyloidosis with limited clinical information has important practical ramifications, particularly for screening, in clinical centers without the time, resource, or expertise to identify Cardiac Amyloidosis from the echocardiogram, which often has an unspecific presentation on the imaging,” it says.

Cardiac amyloidosis is described as a condition where abnormal precursor proteins aggregate to form amyloid fibrils that deposit in the myocardial extracellular matrix, which leads to restrictive cardiomyopathy. “The consequence of the disease is severe, and patients often suffer with increasingly debilitating symptoms and diminishing quality of life, owing to a poor understanding of how to manage their heart failure and frequent, high burden symptoms,” Ultromics 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