Nanox’s HealthFLD, an AI-powered software, has received FDA clearance for automated analysis of liver attenuation from CT scans. This breakthrough technology facilitates early detection of fatty liver, aiding clinicians in diagnosing metabolic diseases. With rising rates of liver-related conditions and limited non-invasive diagnostic methods, HealthFLD’s clearance signifies a transformative step in enhancing patient care and optimizing healthcare workflows. Leveraging advanced AI algorithms, HealthFLD promises to revolutionize liver health assessment and improve outcomes for individuals at risk of metabolic dysfunction-associated steatotic liver disease.
Nanox, a pioneering medical imaging technology company, has achieved a significant milestone with the FDA clearance of its advanced AI-based software, HealthFLD. This innovative software, developed by Nanox’s subsidiary Nanox AI Ltd., has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). HealthFLD is designed to provide automated qualitative and quantitative analysis of liver attenuation from both routine contrast and non-contrast chest and abdomen CT scans, specifically catering to patients aged between 18 to 75 years old.
The primary objective of HealthFLD is to support clinicians in the detection of fatty liver, which is closely associated with hepatic steatosis. Hepatic steatosis serves as an early indicator of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), formerly known as Non-Alcoholic Fatty Liver Disease (NAFLD). With approximately 24% of adults in the United States affected by MASLD or NAFLD, this metabolic disease poses significant public health concerns due to its links to obesity, cardiovascular disease, and type 2 diabetes.
MASLD often progresses silently until it reaches advanced stages, leading to severe liver complications such as cirrhosis and Metabolic Dysfunction-Associated Steatohepatitis (MASH). Moreover, MASLD patients face an increased risk of cardiovascular diseases, which are the leading cause of death among individuals with MASLD. Early diagnosis is crucial for effective management, yet the current gold standard for diagnosis, liver biopsy, is invasive and costly. Hence, the development of HealthFLD holds immense promise in facilitating early detection and improving patient outcomes while reducing the burden on the healthcare system.
Traditional methods of assessing liver attenuation on contrast-enhanced CT scans have posed challenges, limiting the ability of clinicians to detect non-severe cases of MASLD. HealthFLD addresses this gap by offering automated analysis and assessment of fatty liver directly from routine CT scans, thus enhancing clinicians’ capability to identify and manage MASLD more effectively.
The rising prevalence of obesity underscores the growing incidence of liver-related diseases, emphasizing the urgent need for effective treatments for conditions like MASH. With several late-stage drug candidates for MASH in development and the availability of GLP-1 drugs for managing type 2 diabetes and other metabolic diseases, the identification of liver steatosis becomes increasingly relevant in clinical practice.
Erez Meltzer, CEO of Nanox, expressed pride in offering HealthFLD as part of Nanox AI’s suite of cutting-edge, AI-powered population health solutions aimed at addressing chronic diseases of significant public health concern. He highlighted the potential of HealthFLD to provide substantial advantages to the biopharmaceutical industry by facilitating the identification of candidates for clinical trials of much-needed therapies for liver diseases, including MASH.
A retrospective study published in the American Journal of Roentgenology (AJR) in 2023 demonstrated the high performance of HealthFLD in detecting moderate hepatic steatosis in contrast-enhanced CT scans. With a sensitivity of 77.8% and specificity of 93.2% at less than 80 HU, HealthFLD proved to be a reliable tool for the noninvasive quantification of liver fat. Integration of HealthFLD with standard CT scans offers clinicians the opportunity to screen for liver steatosis and signs of MASLD on a population level, thereby facilitating early intervention and treatment.
Dr. Perry J. Pickhardt, lead author of the AJR study, emphasized the importance of automated deep learning tools in detecting diseases at earlier stages, especially in the context of the growing prevalence of metabolic diseases and the availability of more effective treatment options. He expressed optimism about having a solution like HealthFLD available to evaluate early signs of illness from routine imaging, marking a significant advancement in healthcare.
The FDA clearance of HealthFLD marks the third product in Nanox AI’s suite of population health solutions to receive regulatory approval. Prior clearances include HealthCCSng, which detects coronary artery calcium (CAC) associated with coronary artery disease, and HealthOST, which assesses vertebral compression fractures and bone mineral density to aid clinicians in evaluating musculoskeletal diseases of the spine, such as osteoporosis. These advancements underscore Nanox’s commitment to leveraging AI technology to address critical healthcare challenges and improve patient outcomes.
