PETACH TIKVA, Israel - Nanox, known as Nano-X Imaging LTD (NASDAQ: NNOX), an innovative medical imaging technology company, announced today that its subsidiary, Nanox AI Ltd., has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its artificial intelligence (AI) software, HealthFLD. The AI software is designed to provide automated analysis of liver attenuation from CT scans and is intended to aid clinicians in detecting fatty liver, a condition associated with metabolic dysfunction-associated steatotic liver disease (MASLD).
HealthFLD can analyze both contrast and non-contrast chest and abdomen CT scans in patients aged 18 to 75. This clearance marks the third product in Nanox AI's suite of population health solutions to be commercially available. The software aims to support early detection of MASLD, a disease linked to obesity and cardiovascular disease, which affects an estimated 24% of U.S. adults. Early diagnosis is crucial, as MASLD is often asymptomatic until it progresses to more severe stages.
The FDA's decision is based on a study published in the American Journal of Roentgenology, which demonstrated HealthFLD's high performance in detecting at least moderate hepatic steatosis with a sensitivity of 77.8% and specificity of 93.2%. The clearance adds to Nanox's portfolio, which includes FDA-cleared solutions for coronary artery disease and musculoskeletal disease assessment.
Erez Meltzer, CEO of Nanox, expressed pride in the company's growing suite of AI-powered health solutions and noted the potential benefits of HealthFLD for the biopharmaceutical industry, particularly in streamlining candidate identification for clinical trials of liver disease therapies, including those for MASH.
Nanox AI, as a deep-learning medical imaging analytics subsidiary of Nanox, focuses on providing clinicians with actionable insights from routine medical imaging. The company's broader vision includes making diagnostic medicine more accessible and affordable globally through its ecosystem, which encompasses the Nanox.ARC system, Nanox.AI, Nanox.CLOUD infrastructure, and a decentralized marketplace for radiology and cardiology experts.
This news is based on a press release statement from Nanox and provides a factual report on the FDA clearance of HealthFLD, a new AI software for liver health analysis.
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