Ligence secures second FDA 510(k) clearance, adding fully automated Left Ventricular Strain analysis

Lithuania, March 2, 2026 – Ligence announces it has received its second U.S. Food and Drug Administration (FDA) 510(k) clearance for the newest iteration of its AI-powered echocardiography software, Ligence Heart. Building on its initial clearance, the updated platform now features fully automated Left Ventricular Global Longitudinal Strain (LV GLS) analysis and expanded deployment options, including private cloud integration.

Fully automated strain analysis in Ligence Heart.

Unlocking early detection with automated strain analysis

With this latest clearance, Ligence Heart automates this heavy lifting. Using advanced machine learning, the software automatically identifies standard echocardiographic views, detects the cardiac cycle and anatomical borders, and conducts precise contour tracking to generate LV GLS and segmental strain measurements.

While standard echocardiography measurements provide vital information, advanced metrics like LV GLS are increasingly critical for detecting myocardial dysfunction early. However, strain analysis is traditionally a complex, time-intensive process that requires meticulous manual contouring.

Key features in the new Ligence Heart:

    Automated Strain Analysis

    Generates LV GLS and segmental strain measurements alongside standard quantitative automated measures (like biplane LVEF).

    Interactive Strain View UI

    A dedicated interface that empowers clinicians to easily review the AI’s contour tracking, adjust left ventricular segmentation or cardiac cycles.

    Private Cloud Deployment

    Hospitals and healthcare networks can now deploy Ligence Heart on a private cloud, offering flexibility and secure integration into existing clinical workflows.

    Empowering clinicians

    “Global Longitudinal Strain is an incredibly powerful metric for early disease detection, but its adoption is often bottlenecked by how time-consuming it is to measure manually,” said Arnas Karužas, MD, PhD, co-founder and CEO of Ligence. “By automating view classification and contour tracking, we are removing that friction. Our goal is to give clinicians access to these advanced diagnostic metrics instantly, while keeping them firmly in control through our intuitive tools. Now, LV strain measurement is accessible for almost all patients.”

    “Global Longitudinal Strain is an incredibly powerful metric for early disease detection, but its adoption is often bottlenecked by how time-consuming it is to measure manually. By automating view classification and contour tracking, we are removing that friction. Our goal is to give clinicians access to these advanced diagnostic metrics instantly, while keeping them firmly in control through our intuitive tools. Now, LV strain measurement is accessible for almost all patients.”

    Arnas Karužas
    MD, PhD, co-founder and CEO of Ligence

    Expanding the vision for cardiac Imaging

    The addition of LV GLS and private cloud capabilities represents the next step in Ligence’s mission to make high-quality, comprehensive cardiac ultrasound accessible and efficient. By continuously addressing the most time-intensive steps in echocardiography, Ligence is helping cardiology teams reduce backlogs, standardize reporting, and ultimately focus their time on what matters most: patient care.

    Ligence Heart v4.0.0 is available immediately for US healthcare providers.

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