This company, that we’re not allowed to name, announced that its deep-learning medical imaging analytics subsidiary received clearance from the U.S. Food and Drug Administration (FDA) for HealthFLD. This is an artificial intelligence (AI) software that uses automated qualitative and quantitative analysis of liver attenuation from routine CT scans in patients between the ages of 18 to 75. This is a huge deal, because an estimated 24% of U.S. adults are living with MASLD or NAFLD, which is a big problem that can cause other health issues like cardiovascular disease and type 2 diabetes.
This is really significant, because traditionally it’s been tricky to assess liver attenuation on contrast-enhanced scans, which make up a large portion of CT scans. That’s limiting the ability of clinicians to detect non-severe cases of MASLD. But, this new AI software, which has received FDA clearance, was designed to help clinicians in the assessment and analysis of fatty liver in the general population from routine CT scans.
This is the third product across the Nanox AI suite of population health solutions to receive FDA clearance. The FDA previously cleared HealthCCS, a solution that detects coronary artery calcium, and HealthOST, a solution that assesses vertebral compression fractures and bone mineral density to support clinicians in the evaluation and assessment of musculoskeletal disease of the spine. This 2023 study of 2,917 patients demonstrated high performance in the detection of at least moderate hepatic steatosis in contrast-enhanced CT scans.
Now, we all know that metabolic diseases are growing in prevalence and more effective treatment options are becoming available. This new HealthFLD AI software is a big step in the right direction in that department. It can help clinicians extract valuable and actionable clinical insights from routine medical imaging to improve health outcomes. This is exactly what we need more of in the medical field.