Ligence Heart receives FDA 510(k) clearance
Lithuania, November 26th, 2025 – Ligence announces that its AI-powered echocardiography software, Ligence Heart, has received U.S. Food and Drug Administration (FDA) 510(k) clearance. Ligence Heart, is an AI-powered software that automates measurements and analysis of 2D transthoracic echocardiography (TTE) images and produces a structured report with several key cardiac structural and functional parameters. The clearance enables U.S. healthcare providers to generate reliable and reproducible cardiac measurements, addressing time-consuming tasks in echocardiography analysis.
