The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to Nanox’s HealthFLD artificial intelligence software. This software is designed to assist clinicians in detecting fatty liver associated with hepatic steatosis. HealthFLD aims to facilitate the early detection of liver steatosis by providing automated qualitative and quantitative assessments of liver attenuation from routine chest and abdomen CT scans for patients aged 18 to 75 years.
A key feature of the HealthFLD software is its ability to analyze contrast-enhanced CT scans with high accuracy. In a retrospective study involving 2,917 patients, HealthFLD demonstrated a sensitivity of 77.8% and a specificity of 93.2% in detecting at least moderate hepatic steatosis. This advancement is particularly significant as metabolic diseases are increasingly prevalent, and more effective treatment options are becoming available.
HealthFLD is the third product in the Nanox AI suite to receive FDA clearance, following HealthCCSng for coronary artery disease and HealthOST for the assessment of musculoskeletal spine disease. Erez Meltzer, CEO of Nanox, highlighted the potential of AI solutions like HealthFLD to improve health outcomes and aid in the identification of candidates for clinical trials for liver diseases, including metabolic dysfunction-associated steatohepatitis.
The FDA’s decision underscores Nanox’s position as a leader in developing automated AI software medical devices, offering new tools for early disease detection and management.
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