Us2.ai Echocardiography AI: FDA-Cleared Multi-Parameter Cardiac Analysis Deployed at Mayo Clinic + Bordeaux + 5 Indian Hospitals (2022-2026)

Title

Us2.ai Echocardiography AI: FDA-Cleared Multi-Parameter Cardiac Analysis Deployed at Mayo Clinic + Bordeaux + 5 Indian Hospitals (2022-2026)

Content

Us2.ai, the Singapore-based clinical AI company founded in 2017, has deployed the first FDA-cleared fully automated multi-parameter echocardiography analysis platform in major hospitals worldwide, automating measurement of 10+ cardiac parameters including left ventricular ejection fraction (LVEF), global longitudinal strain (GLS), right ventricular size and function, valvular function, and diastolic function. The Us2.ai software received FDA 510(k) clearance in 2022 (also CE Mark and Singapore HSA approved) for deep learning analysis of 2D and Doppler transthoracic echocardiography. The platform generates a comprehensive report in under 2 minutes without expert input, dramatically reducing the specialist time required per study. The platform is deployed at Bordeaux University Hospital (France), which performs 21,000 echocardiograms per year and completed technical integration in less than 4 weeks from receiving the AI server to capturing first cases. A 2026-published prospective multicentre study across five tertiary hospitals in India enrolled 202 adult patients, with key results including LVEF correlation r=0.845 (mean difference -1.9%), 91% correct classification of LV systolic function, 96% correct classification of LV diastolic dysfunction, and 100% identification of pulmonary hypertension. Mayo Clinic launched the 10 million patient Deep Learning for Echo Analysis, Tracking, and Evaluation trial (NCT07308704) in February 2026, a stepped-wedge clinical trial with EHR-based notifications evaluating AI-Echo for genetic cardiomyopathy, ischemic heart disease, cardiac amyloidosis, and hypertrophic cardiomyopathy detection. Architecture spans deep learning analysis of 2D and Doppler transthoracic echocardiography, automated measurement of 10+ cardiac parameters, cloud-based processing via the Us2.ai platform, and integration with hospital PACS systems for real-time AI-assisted interpretation. The system completes a comprehensive report in under 2 minutes. Operational scale covers Bordeaux University Hospital performing 21,000 echocardiograms per year, the Mayo Clinic 10 million patient trial, the 5-hospital Indian multicentre study with 202 enrolled patients, and FDA clearance plus CE Mark and Singapore HSA approvals. Technical integration completed in under 4 weeks from AI server delivery to first cases at Bordeaux. Looking ahead, Us2.ai plans to expand FDA-cleared parameters, broader European hospital integration, and integration with hospital PACS systems for real-time AI-assisted interpretation, building on the strong clinical validation across multiple geographies and care settings.