The AI-enabled HealthFLD software demonstrated a 77.8 percent sensitivity rate and a 93.2 percent specificity rate for diagnosing moderate hepatic steatosis on contrast-enhanced CT scans in a recent study of over 2,900 patients.
The Food and Drug Administration (FDA) has granted 510(k) clearance for HealthFLD, an artificial intelligence (AI)-powered software, which provides automated liver attenuation analysis based on contrast and non-contrast computed tomography (CT) scans.1
HealthFLD reportedly provides adjunctive support in detecting fatty liver, the initial stage of hepatic steatosis, which may be an early indicator of metabolic dysfunction-associated steatotic liver disease (MASLD), a disease that reportedly affects 24 percent of adults in the United States, according to Nanox, the developer of HealthFLD.
In a 2023 retrospective study that examined the use of HealthFLD for detecting moderate hepatic steatosis on contrast-enhanced CT scans, researchers noted a 77.8 percent sensitivity rate and a 93.2 percent specificity rate at less than 80 HU.2
“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, the chief executive officer of Nanox.
References
1. Nanox. Nanox receives FDA clearance for HealthFLD, an advanced AI-based software empowering clinicians in assessment of fatty liver. GlobeNewswire. Available at: https://www.globenewswire.com/news-release/2024/02/13/2828223/0/en/Nanox-Receives-FDA-Clearance-for-HealthFLD-an-Advanced-AI-Based-Software-Empowering-Clinicians-in-Assessment-of-Fatty-Liver.html . Published February 13, 2024. Accessed February 13, 2024.
2. 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. AJR Am J Roentgenol. 2023;221(6):748-758.
Stay at the forefront of radiology with the Diagnostic Imaging newsletter, delivering the latest news, clinical insights, and imaging advancements for today’s radiologists.
Mammography Study: AI Facilitates Greater Accuracy and Longer Fixation Time on Suspicious Areas
July 8th 2025While noting no differences in sensitivity, specificity or reading time with adjunctive AI for mammography screening, the authors of a new study noted a 4 percent higher AUC and increased fixation time on lesion regions.