Devices

Nanox Fatty Liver Detector Cleared by FDA

FDA has cleared a Nanox AI 510(k) for HealthFLD, an artificial intelligence (AI) software that provides automated qualitative and quantitative analysis of liver attenuation from routine contrast and non-contrast chest and abdomen computed tomography scans in patients between the ages of 18 to 75. The company says HealthFLD is intended to support clinicians in detecting fatty liver, correlated with hepatic steatosis, an early sign of metabolic dysfunction-associated steatotic liver disease.

AI assessment has traditionally been difficult to assess liver attenuation on contrast-enhanced scans, according to the company, and HealthFLD was designed to help clinicians in these assessments. “With several late-stage drug candidates for [metabolic dysfunction-associated steatohepatitis] MASH in development and the availability of GLP-1 drugs for the management of Type 2 diabetes and other metabolic diseases, identification of liver steatosis is especially relevant,” it adds.

Clearance was based on data from a retrospective 2023 study of 2,917 patients. In the study, HealthFLD AI software “demonstrated high performance in the detection of at least moderate hepatic steatosis in contrast-enhanced CT scans, with a sensitivity of 77.8% and specificity of 93.2%,” the company 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