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.
Related: iCardio.ai wins second FDA 510(k) clearance for CardioVision
Why this clearance matters
The number of cardiac diseases each year continues to rise. Manual measurements and reporting consume valuable clinician time, often creating backlogs and adding pressure on already-stretched cardiology teams. Ligence Heart automatically performs key cardiac measurements and generates a clinical report. It is engineered for consistency and operational efficiency with the goal of reducing repetitive manual work and creating a standardised workflow.
Saving clinicians time for actual patient care
“As a cardiologist myself, I know that we spend far too much time on repetitive manual tasks. Instead we should be focusing on increasing the accuracy of heart disease detection, especially heart failure. Automating core TTE measurements is a significant step towards that,” said Arnas Karužas, MD, co-founder and CEO of Ligence. “With FDA clearance, clinicians in the U.S. can now use Ligence Heart to reduce the workload in echo labs and improve overall workflow efficiency.”
With FDA 510(k) clearance, Ligence Heart can now be used in the United States for automated and manual analysis of adult 2D TTE images and reporting. To support the 510(k) submission, Ligence Heart underwent a clinical validation study at an independent U.S. echocardiography core laboratory.
Ligence’s vision for the future of cardiac imaging
Ligence’s mission is to create a future where high-quality cardiac ultrasound is accessible across all areas of medicine, not just advanced cardiology centers. By automating time-intensive steps, the company aims to support earlier disease detection, reduce variability, and create a more efficient echo workflow.
Ligence is going to continue investing in expanding Ligence Heart’s capabilities and regulatory footprint in the United States, with additional 510(k) submissions planned to further enhance the platform for clinicians and healthcare systems.
