FDA grants 510(k) clearance to Nanox AI software to assess ‘early signs’ of fatty liver
Click Here to Manage Email Alerts
The FDA has granted 510(k) clearance to Nanox’s HealthFLD artificial intelligence software to aid clinicians in the detection of fatty liver associated with hepatic steatosis, according to a company press release.
The HealthFLD software is intended to support early detection of liver steatosis by providing physicians with automated qualitative and quantitative assessment of liver attenuation from routine chest and abdomen CT scans in patients aged 18 to 75 years, the release stated.
The FDA based its decision on a retrospective study of 2,917 patients, in which the HealthFLD 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%.
“In recent years, automated, deep learning tools have offered an efficient, low-cost tool used to detect diseases in earlier stages,” lead study author, Perry J. Pickhardt, MD, from the University of Wisconsin School of Medicine & Public Health, said in the release. “We are now at a watershed moment when metabolic diseases are growing in prevalence and more effective treatment options are becoming available. It’s promising to have a liver solution available that may help evaluate early signs of illness from routine imaging.”
The company noted this is the third product in the Nanox AI suite to receive FDA clearance, following its HealthCCSng for coronary artery disease and HealthOST for the assessment of musculoskeletal spine disease.
“We are proud to offer HealthFLD as the third product of Nanox AI’s suite of cutting-edge, AI-powered population health solutions designed to confront chronic diseases of great public health concern head-on, and potentially improve health outcomes,” Erez Meltzer, CEO of Nanox, said in the release.
“We believe that AI innovative solutions, and specifically HealthFLD, may deliver substantial advantages to the biopharmaceutical industry to streamline the identification of candidates for clinical trials of much-needed therapies for liver diseases, including [metabolic dysfunction-associated steatohepatitis],” he added. “This regulatory decision solidifies our leadership as a developer of automated AI software medical devices.”
Click Here to Manage Email Alerts