Ligence Heart

by Ligence  · Based in Lithuania → — Echocardiography that makes sense.
Cardiology
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Regulatory Status Disclosed

Overview

Ligence Heart is an AI-powered software designed to automate the analysis and reporting of 2D transthoracic echocardiography (TTE) images. It aims to streamline the workflow for cardiologists and sonographers by capturing images at the ultrasound machine and automatically annotating and generating reports. The software performs automated recognition of echocardiography imaging data, including probe position, and detects anatomical features like heart chamber borders and landmarks. It transfers echocardiography images (with PHI removed) from hospital PACS to Ligence Heart, performs automated view classification, predicts annotations and heart phases, and calculates measurements to generate comprehensive reports.

The solution helps clinicians understand visual echocardiography data, improving the management of cardiology patients. It allows for automated evaluation of echocardiography images with non-inferior accuracy compared to cardiologists, reduces intra-rater variability of measurements, and significantly saves time by automating image evaluation and report generation. Ligence Heart integrates seamlessly with existing PACS and EHR systems, supports various clinical guidelines (EACVI, BSE, ASE), and provides intuitive tools for accurate measurement and reporting.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Automated recognition of echocardiography imaging data
  • Automated view classification and heart phase prediction
  • Automated calculation of measurements and report generation
  • Transfer of echocardiography images (PHI removed) from hospital PACS
  • Area, Distance, Doppler, and Volume quantification
  • Disease recognition (Heart failure, cardiomyopathy, pulmonary hypertension, valvular heart diseases)
  • Automated strain, Spectral and Tissue Doppler measurements
  • Integration with existing systems (PACS, EHR, RIS)
  • Guideline-based reporting (EACVI, BSE, ASE)
  • Clinical decision support

Use Cases

  • Automating 2D transthoracic echocardiography (TTE) analysis and reporting
  • Improving diagnostic efficiency and accuracy in cardiology
  • Reducing manual workload for cardiologists and sonographers
  • Standardizing echocardiography reporting and measurements
  • Supporting earlier disease detection and better patient risk stratification
  • Retrospective analysis of large cohorts

What Physicians Need to Know

ECG/EKG Analysis Capability
While Ligence Heart may process ECG data, it is explicitly stated that this data is not intended for diagnostic purposes within the software.
Echocardiography AI Features
Ligence Heart provides AI-powered automated analysis and reporting for 2D transthoracic echocardiography (TTE) images. It automates the recognition of imaging data, probe position, anatomical features, view classification, heart phase prediction, measurements, and report generation. The system also includes automated strain, Spectral, and Tissue Doppler measurements. It achieves non-inferior accuracy compared to cardiologists and significantly reduces intra-rater variability in measurements.
Cardiac CT/MRI Analysis
Ligence Heart is primarily focused on echocardiography analysis. However, Ligence has a strategic partnership with AI4CMR to deliver a combined multimodality solution that incorporates cardiac MRI analysis.
Arrhythmia Detection Accuracy
Ligence Heart lists 'Real-time arrhythmia detection' as a feature. However, its automated echocardiography functionalities are contraindicated for patients with heart arrhythmias (e.g., atrial flutter, atrial fibrillations).
Heart Failure Risk Prediction
The tool assists in the diagnosis, risk stratification, and monitoring of heart failure by providing detailed echocardiographic assessments of left ventricular systolic and diastolic function, structural abnormalities, and valvular function. It also offers general risk stratification and predictive analytics capabilities.
Cardiac Monitoring Integration
Ligence Heart integrates seamlessly with existing hospital systems, including PACS, EHR, CIS, and RIS. It also supports integration with medical devices and wearable health monitors.
AHA/ACC Guideline Alignment
The software generates guideline-based reports that align with standards from organizations such as EACVI, BSE, and ASE. It also supports new patient-specific algorithms for assessing left ventricular diastolic function as recommended by the British Society of Echocardiography.
Real-Time Alert Capability
Features include patient monitoring and alerting, with customizable alert thresholds available as an optional module. It can provide near real-time feedback on image view and quality during data acquisition. The AI can also alert clinicians to potential drug interactions or worsening patient conditions.
Physician Tip

Leverage Ligence Heart to significantly reduce the manual workload and reporting time associated with 2D transthoracic echocardiography, allowing more focus on patient interaction and complex decision-making. Always review and validate AI-generated measurements and reports, especially in cases with contraindications like arrhythmias or complex congenital heart disease, as the software is intended as an additional support tool, not a replacement for clinical judgment. Utilize its guideline-aligned reporting to ensure consistency and adherence to standards.

Ligence Heart is designed for seamless integration with existing hospital infrastructure, including PACS, EHR, CIS, and RIS systems. It supports DICOM data input and various output formats (CSV, Free text, PDF, Web). Custom integration solutions and APIs are available to work with unique or in-house software, ensuring broad compatibility within diverse healthcare IT environments.

Details

Category Cardiology AI
Pricing Contact-for-pricing — Contact vendor for pricing, demos, and trial information; enterprise_quote model.
DeploymentCloud-based; on-premise; hybrid
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

Ligence Heart received U.S. Food and Drug Administration (FDA) 510(k) clearance on November 26, 2025, for automated and manual analysis of adult 2D TTE images and reporting. It also secured a second FDA 510(k) clearance for fully automated Left Ventricular Strain analysis.
Integrations
EHR Not specified
Specialties Cardiology

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Clinical Value
Ease of Use
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Press & Coverage

Disruptivity Times
Ligence Heart Deploys Universal AI Copilot for Echocardiography
Ligence Heart has launched a universal AI copilot for echocardiography, integrating with major cardiac ultrasound machines across Europe. This platform automates complex cardiac measurements, significantly reducing analysis time and inter-operator variability.
2026-07
Ligence (Uncategorized News)
Ligence secures second FDA 510(k) clearance, adding fully automated Left Ventricular Strain analysis
Ligence received its second U.S. FDA 510(k) clearance for Ligence Heart in April 2026, which now includes fully automated Left Ventricular Global Longitudinal Strain (LV GLS) analysis and expanded deployment options.
2026-04
LSMU
Successful U.S. Market Entry by Lithuanian Medical Startup: Solution that Redefines Routine Clinical Practice is the Key
Ligence, a Lithuanian MedTech company, received FDA 510(k) approval for its AI-based cardiac ultrasound software, Ligence Heart, enabling its use in U.S. healthcare institutions for automated heart measurement analysis and structured reporting.
2026-01
Innolitics
2025 Year in Review: Cardiology AI/ML SaMD 510(k) Clearances
Ligence Heart received FDA 510(k) clearance on September 26, 2025, as part of a trend of cardiology AI/ML SaMD clearances in 2025 focusing on heart failure screening, EF estimation, and valvular disease.
2026-01
Ligence
Ligence Heart receives FDA 510(k) clearance
Ligence announced on November 26, 2025, that its AI-powered echocardiography software, Ligence Heart, received U.S. Food and Drug Administration (FDA) 510(k) clearance. This clearance allows U.S. healthcare providers to use Ligence Heart for automated measurements and analysis of 2D transthoracic echocardiography images.
2025-11
EIC Scaling Club
Ligence: Bringing AI innovation to the heart of cardiac diagnostics - EIC Scaling Club
Ligence's AI software automates cardiac measurements and report generation, aiming to save cardiologists time, improve accuracy, and enhance patient care. A study at the University Clinic of Technische Universitu00e4t Dresden validated Ligence Heart, showing AI outperformed humans in echocardiography.
2025-11
Ligence
Ligence Attracts u20ac3 Million Investment
Ligence secured u20ac3 million in seed funding, led by Simpact Ventures and including a convertible loan from the European Innovation Council (EIC) Fund. This funding will support Ligence's expansion and preparation for FDA clearance, anticipated in early 2025.
2025-01
Ligence
Ligence receives Certificate for the Ligence Heart AI system
Ligence Heart analysis and reporting system for transthoracic echocardiography has been certified under MDR 2017/745, regulating it as a medical device class IIa in Europe. The system will be offered to care centers in Europe, with initial sales expected in Lithuania and the Baltic region.
unknown

Videos

Product demos, reviews, and walkthroughs for Ligence Heart.

View all on YouTube

Frequently Asked Questions

Ligence Heart is a web-based, fully integrated echocardiography analysis suite designed to streamline the workflow by automating measurements and analysis of 2D transthoracic echocardiography (TTE) images. It automatically recognizes imaging data, classifies views, predicts annotations, calculates measurements, and generates structured reports, which clinicians can then review and approve.
Ligence Heart has received FDA 510(k) clearance in the U.S. and is CE-Marked, regulated as a Class IIa medical device under MDR 2017/745 in Europe. The platform supports regulatory compliance and incorporates privacy features such as Business Associate Agreements (BAA), consent management, data anonymization, and minimization to protect patient information.
Ligence Heart's accuracy can be affected by poor image capture, suboptimal echo machine settings, or lack of ECG data. It is not validated for congenital heart disease, valve disease, pericardial disease, or intra-cardiac lesions in the U.S. market, and is intended for adult patients in sinus rhythm, not for emergency diagnoses.
Ligence Heart aims to provide measurements with non-inferior accuracy compared to cardiologists and reduces intra-rater variability. Clinical validation studies have supported its regulatory clearances, demonstrating its ability to generate reliable and reproducible cardiac measurements.
While several companies offer cardiac monitoring and AI solutions, Ultromics is noted as a leader in AI for echocardiography, focusing on heart failure detection and risk stratification. Ligence Heart differentiates itself by offering a fully automated, web-based suite for 2D TTE analysis and reporting, emphasizing workflow efficiency and time savings for cardiologists and sonographers.
Ligence Heart generally operates on a pricing model that includes a one-time license fee, which is typically based on the number of installations. Specific pricing details are usually obtained by contacting the vendor directly for a customized quote, as costs can vary depending on the scale of deployment and specific institutional needs.
No, Ligence Heart is designed as a support tool to complement good patient care and does not replace medical professionals. Physicians retain full responsibility for supervising the software, clinically reviewing patients, and making all appropriate clinical decisions.

Compare Ligence Heart

VS
Ligence Heart vs Cardiomo
Cardiology AI Adjacent · 60/100
Ligence Heart is designed for clinical settings, automating echocardiography analysis for cardiologists and sonographers to enhance diagnostic efficiency. Cardiomo, on the other hand, focuses on continuous and remote…
VS
Ligence Heart vs PMcardio
Cardiology AI Adjacent · 65/100
These tools are adjacent in their focus on cardiac diagnostics but differ significantly in their input data and specific applications. Ligence Heart specializes in automating the analysis of…
VS
Ligence Heart vs EchoNext
Cardiology AI Adjacent · 75/100
Both Ligence Heart and EchoNext are AI-powered tools focused on cardiology, specifically aiding in the diagnosis of heart conditions. However, Ligence Heart specializes in automating the analysis and…
VS
Ligence Heart vs KardiaPro
Cardiology AI Adjacent · 65/100
Ligence Heart and KardiaPro are adjacent tools in cardiology AI, both offering FDA-cleared solutions. Ligence Heart focuses on automating the analysis and reporting of 2D transthoracic echocardiography for…

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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18
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