Nano-X Imaging receives FDA clearance for HealthFLD

Nano-X Imaging announced that its deep-learning medical imaging analytics subsidiary, Nanox AI, received 510(k) clearance by the U.S. Food and Drug Administration for HealthFLD. HealthFLD is intended to support clinicians in the detection of fatty liver, correlated with hepatic steatosis, an early sign of metabolic dysfunction-associated steatotic liver disease, formerly referred to as non-alcoholic fatty liver 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,” said Erez Meltzer, Chief Executive Officer of Nanox. “Furthermore, 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 MASH. This regulatory decision solidifies our leadership as a developer of automated AI software medical devices.”