FDA Grants 510(k) Clearance to Liver Attenuation AI Software HealthFLD

Perry Pickhardt, MD

Credit: University of Wisconsin-Madison

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Nanox’s HealthFLD, an artificial intelligence software that provides automated qualitative and quantitative analyses of liver attenuation from routine contrast and non-contrast chest and abdomen CT scans in patients 18-75 years of age.¹

The press release pointed to rising obesity rates and a subsequent growing prevalence of liver-related disease, citing the need for a reliable, noninvasive method for quantifying liver fat – integrating HealthFLD with widely used standard CT scans may offer a potential solution, giving clinicians the tools to opportunistically screen for liver steatosis and possible signs of metabolic dysfunction-associated steatotic liver disease (MASLD) on a population level.¹

“In recent years, automated, deep learning tools have offered an efficient, low-cost tool used to detect diseases in earlier stages,” said Perry Pickhardt, MD, chief of gastroenterological imaging at the University of Wisconsin School of Medicine and Public Health and medical director of oncological imaging at the University of Wisconsin Carbone Cancer Center.¹ “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 release also pointed to the need for tools to aid the early identification of liver steatosis in the absence of an approved treatment. Of note, new data from the phase 3 MAESTRO-NASH trial were published earlier this month, with results showing resmetirom, a thyroid hormone receptor (THR)-β selective agonist designed to target key underlying causes of nonalcoholic steatohepatitis (NASH) in the liver, helped patients achieve NASH resolution with no worsening of fibrosis as well as fibrosis improvement by ≥ 1 stage with no worsening of the nonalcoholic fatty liver disease (NAFLD) activity score. With the drug’s March 14 PDUFA date on the horizon, resmetirom may soon become the first and only FDA-approved treatment for the progressive liver disease.^1,2

Designed to help clinicians in the assessment and analysis of fatty liver in the general population from routine CT scans, HealthFLD is the third product across the Nanox AI suite of population health solutions to receive FDA clearance. HealthCCSng, a solution that detects coronary artery calcium that presents a risk for coronary artery disease, 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, were both previously cleared by the FDA.¹

In a retrospective study of 2917 patients who underwent a CT examination including ≥ 2 series through the liver, the HealthFLD AI software 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% at < 80 HU. The automated deep learning tool extracted liver and spleen attenuation measurements, and postcontrast liver attenuation outperformed the postcontrast liver-spleen attenuation difference for detecting at least moderate steatosis.³

“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,” said Erez Meltzer, Chief Executive Officer of Nanox.¹

References:

1. ^{Nanox. Nanox Receives FDA Clearance for HealthFLD, an Advanced AI-Based Software Empowering Clinicians in Assessment of Fatty Liver. Press Releases. February 13, 2024. Accessed February 13, 2024. https://investors.nanox.vision/news-releases/news-release-details/nanox-receives-fda-clearance-healthfld-advanced-ai-based}
2. ^{Brooks, A. Stephen Harrison, MD: Promising Phase 3 Data for Resmetirom in NASH, Fibrosis. HCPLive. February 7, 2024. Accessed February 13, 2024. https://www.hcplive.com/view/stephen-harrison-md-promising-phase-3-data-resmetirom-nash-fibrosis}
3. ^{Pickhardt PJ, Blake GM, Kimmel Y, et al. Detection of Moderate Hepatic Steatosis on Portal Venous Phase Contrast-Enhanced CT: Evaluation Using an Automated Artificial Intelligence Tool. American Journal of Roentgenology. https://doi.org/10.2214/AJR.23.29651}