CardioVision™
Auto detect aortic stenosis from ultrasound
Company profile
Company profile
iCardio.ai is a Los Angeles-based company pioneering the application of artificial intelligence to echocardiography and ultrasound interpretation. The company has developed a comprehensive suite of AI-powered tools designed to automate and enhance the analysis of cardiac ultrasound imaging. Leveraging a database of over 200 million individual echocardiographic images from hundreds of thousands of de-identified patients, iCardio.ai builds machine learning algorithms that address the significant challenges in cardiac imaging interpretation. The company's flagship products include EchoMeasure™, an FDA 510(k)-cleared solution that automates over a dozen standard cardiac measurements including ejection fraction, chamber dimensions, and wall thickness assessments. CardioVision™, which has received both FDA 510(k) clearance and FDA Breakthrough Device Designation, automatically detects aortic stenosis from parasternal long axis clips, addressing a critical diagnostic need in cardiovascular care. Additional tools include EchoCheck for image quality assessment, EchoGPT for image-to-text analysis, and various quantitative and qualitative interpretation modules. iCardio.ai partners with ultrasound equipment manufacturers and PACS providers to integrate its technology directly into clinical workflows. The company collaborates with world-leading cardiologists and AI scientists to create comprehensive automated analysis of echocardiograms at an unprecedented scale. Their solutions aim to reduce inter-reader variability, minimize work-related musculoskeletal disorders among sonographers, and ensure that critical conditions like aortic stenosis are never missed. The company serves health systems, cardiology practices, and imaging centers, with integrations available through major PACS systems including UltraLinQ.
Company description Icardio.Ai official website
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01 · Operating footprint
Company-profile context for clinical focus, customers, deployment, integration, milestones, and partnerships.
Api Only · Cloud Saas · Other deployment with recorded integration context.
Recorded integration context: Multiple PACS systems, UltraLinQ PACS.
Company milestones
FDA 510(k) clearance for CardioVision™ for Aortic Stenosis (November 2024); FDA Breakthrough Device Designation for CardioVision™; Partnership with UltraLinQ PACS (January 2024); Second FDA 510(k) clearance received
Partnerships
02 · Flagship portfolio
Selected source-backed Company products and the available commercial context.
Auto detect aortic stenosis from ultrasound
Access large collection of echo data for research
Track image quality and echo completeness
Describe ultrasound images with AI
Automated echo measurements with AI precision
Get echos read by top cardiologists assisted by AI
03 · Research intelligence
Publications, preprints, clinical validation, and regulatory records in Evidence Position order.
Publications, clinical validation, and regulatory records connected to this Company appear here.
Research
Journal of the American Society of Echocardiography : official publication of the American Society of Echocardiography · Jul 14, 2026
Accuracy of a Deep Learning Model in Intracardiac Echocardiography.JACC. Advances · Jun 15, 2026
Automated Detection of Aortic Stenosis Using Machine Learning.Journal of the American Society of Echocardiography : official publication of the American Society of Echocardiography · Apr 1, 2023
Clinical validation
No linked records are currently available.
Regulatory
K251293 · 510k · Nov 21, 2025
EchoMeasureK241430 · 510k · Oct 10, 2024
04 · Company-reported outcomes
Company-reported outcomes and customer stories are distinct from linked Research Intelligence evidence.
Automated interpretation of echocardiography
EchoMeasure™ addresses this by automating repetitive measurement tasks
From addressing 105,000+ untreated aortic stenosis patients eligible for intervention
CardioVision™ aims to improve detection and treatment rates
Integration of iCardio.ai's automated AI tools into UltraLinQ's PACS platform to enhance ultrasound image interpretation, assess exam quality, and automate workflows
Enhanced quality, efficiency, accuracy, and speed in ultrasound image interpretation across UltraLinQ's PACS user base
05 · Leadership
Leadership profiles and professional links from the current Company record.
06 · Company updates
Recent articles published on Icardio.Ai's official website.
07 · HAIC coverage
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08 · Official presence
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09 · Market pathway
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Market context
Companies applying AI to cardiovascular disease detection, ECG/EKG analysis, heart failure management, cardiac imaging, arrhythmia detection, or cardiovascular risk assessment. Includes AI-powered cardiac diagnostics, non-invasive hemodynamic monitoring, and tools for early detection and personalized management of heart conditions.
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