ContextVision begins clinical trial for AI-powered liver disease diagnostic

ContextVision, a leader in medical imaging software, has commenced the clinical phase of its LYNX project at the University of Washington. The project aims to develop a quantifiable ultrasound biomarker for hepatic steatosis (MASLD). This milestone follows successful Institutional Review Board approval and technical validation. The study, registered as NCT07270601 on ClinicalTrials.gov, seeks to create a non-invasive, quantitative diagnostic tool to quantify hepatic steatosis, evaluating it against the gold standard MRI-PDFF.

The clinical phase will enroll 110 subjects over the next year, encompassing healthy volunteers and patients across the MASLD spectrum. Participants will undergo imaging using ContextVision's proprietary ultrasound sequences, alongside comparative imaging with existing devices like EchoSense FibroScan and Philips EPIQ Elite Ultrasound, as well as a Philips 3T Ingenia Elition MRI system. This initiative is part of ContextVision’s broader data quality program, focusing on AI-powered, organ-specific quantitative imaging solutions.

MASLD currently affects approximately 1.8 billion individuals globally and is a leading cause of chronic liver disease. Early diagnosis is often hampered by the reliance on invasive or costly methods. ContextVision's AI-based liver imaging program aims to bridge this gap by providing accessible, cost-effective, and scalable imaging tools in collaboration with partners such as AMRA Medical and the University of Waterloo’s LITMUS Lab.