Cardiac Guidance

by Caption Health  · Based in United States →AI-Guided Ultrasound for Early Disease Detection and Accessible Cardiac Care
Cardiology Emergency Medicine Radiology

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Regulatory Status Disclosed

Overview

Caption Health, acquired by GE HealthCare in February 2023, is a pioneer in AI-powered medical imaging solutions. Its flagship product, Cardiac Guidance (also known as Caption Guidance, part of the Caption AI platform), is an FDA-cleared software designed to democratize access to high-quality cardiac ultrasound. The tool leverages artificial intelligence to guide healthcare professionals, including those without extensive sonography experience, through the process of acquiring diagnostic-quality echocardiographic images in real time.

Caption Guidance provides turn-by-turn on-screen instructions for probe movements, offers automated feedback on image quality via a ‘Quality Meter,’ and can auto-capture optimal video clips. It works in conjunction with Caption Interpretation, which automatically calculates left ventricular ejection fraction (EF), a key measure of heart function. This technology aims to expand the availability of cardiac assessments in various point-of-care settings, enabling earlier detection and improved patient outcomes.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Real-time AI guidance for cardiac ultrasound image acquisition
  • Turn-by-turn on-screen probe movement instructions
  • Automated quality assessment with a 'Quality Meter'
  • Auto-capture of diagnostic-quality images and video clips
  • Automated left ventricular ejection fraction (EF) calculation (Caption Interpretation)
  • Support for 10 standard echocardiographic views (e.g., PLAX, AP4, AP2)
  • Compatibility with point-of-care ultrasound systems
  • Designed for use by non-expert ultrasound users

Use Cases

  • Point-of-care cardiac assessments in emergency departments and critical care units
  • Early detection of heart disease and cardiac dysfunction
  • Screening and monitoring for heart failure
  • Cardiovascular risk assessment in patients with hypertension or diabetes
  • Cardiac function assessment in cardio-oncology and renal patients
  • Training and enablement for healthcare professionals without prior ultrasound expertise

What Physicians Need to Know

ECG/EKG Analysis Capability
Caption Health's primary focus is on echocardiography. There is no information indicating that their 'Cardiac Guidance' or 'Caption AI' tools directly provide ECG/EKG analysis capabilities.
Echocardiography AI Features
Caption AI, comprising Caption Guidance and Caption Interpretation AutoEF, offers real-time visual guidance for probe manipulation to acquire diagnostic-quality cardiac ultrasound images across 10 standard views (e.g., PLAX, AP4, AP2). It includes a 'Quality Meter' for real-time image quality assessment, auto-capture of optimal clips, and automated calculation of Left Ventricular Ejection Fraction (LVEF) from various views. The LVEF calculation is clinically validated and comparable to expert quantitative measurements, also providing a qualitative assessment of global LV function based on guidelines.
Cardiac CT/MRI Analysis
Caption Health's AI tools are specifically designed for ultrasound imaging. There is no information suggesting capabilities for Cardiac CT or MRI analysis.
Arrhythmia Detection Accuracy
The provided information does not indicate that Caption Health's 'Cardiac Guidance' or 'Caption AI' tools are designed for or provide arrhythmia detection capabilities.
Heart Failure Risk Prediction
Caption Care, powered by Caption AI, aims to facilitate earlier detection and management of heart disease, including heart failure, by making echocardiograms more accessible. The technology assists in assessing left ventricular size and function, right ventricular size and function, and pericardial effusion, which are critical for heart failure assessment. Programs utilizing Caption Care have shown findings rates consistent with at least Stage B heart failure in 25-50% of patients.
Coronary Artery Assessment
Caption Health's AI tools primarily focus on cardiac structure and function via echocardiography. There is no information indicating capabilities for coronary artery assessment.
Cardiac Monitoring Integration
While Caption Health partners with various healthcare entities for service delivery, there is no explicit mention of direct integration with cardiac monitoring devices (e.g., Holter monitors, insertable cardiac monitors) for data input or analysis by the Caption AI platform itself. Integrations focus on ultrasound hardware and virtual cardiology services.
AHA/ACC Guideline Alignment
Caption Care aims to align with cardiac screening and monitoring guidelines, specifically referencing the 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure and the 2010 ACCF/AHA Guideline for Assessment of Cardiovascular Risk in Asymptomatic Adults, which recommend echocardiography for suspected heart failure and cardiovascular risk assessment. The qualitative assessment of global LV function provided by Caption AI AutoEF is mapped to categories based on American Society of Echocardiography (ASE) and American College of Emergency Physicians (ACEP) guidelines.
Real-Time Alert Capability
Caption Guidance provides real-time visual prompts and feedback to guide users in acquiring diagnostic-quality images. The 'Quality Meter' acts as a real-time indicator, turning green when optimal image quality is achieved, followed by automatic clip capture.
Physician Tip

Caption AI (Guidance and Interpretation) empowers clinicians, including those without extensive sonography experience, to acquire diagnostic-quality cardiac ultrasound images and automatically calculate ejection fraction at the point of care. This technology can significantly expand access to echocardiography for early detection and management of heart conditions, particularly heart failure, in various settings including emergency departments, critical care, and even home care. The real-time guidance and automated quality assessment features help standardize image acquisition and reduce variability, leading to more consistent and reliable diagnostic information. The automated ejection fraction calculation provides a quick and accurate assessment of cardiac function, comparable to expert quantitative measurements.

Caption Health's AI software (Caption Guidance and Caption Interpretation) is designed for integration with compatible ultrasound devices. It has been integrated with GE HealthCare's Vscan Air SL wireless handheld ultrasound system and Venue Family point-of-care ultrasound systems. Additionally, Caption Health has partnered with Butterfly Network to integrate its AI into the Butterfly iQ+ platform. For service delivery, Caption Care collaborates with networks of medical technicians (e.g., Portamedic) for in-home exams and with virtual cardiology companies (e.g., Heartbeat Health) for remote interpretation and care management services.

Details

Category Cardiology AI, Radiology & Imaging AI
Pricing Contact vendor Contact Vendor
DeploymentSoftware accessory integrated with compatible general purpose diagnostic ultrasound systems (e.g., GE HealthCare Venue Family, Vscan Air SL, Terason uSmart 3200t Plus).
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

Caption Guidance received De Novo FDA authorization (DEN190040) on February 13, 2020, as the first AI-guided medical imaging acquisition system for cardiac ultrasound. It is classified as a Class II Medical Device (Product Code QJU) and was granted Breakthrough Device designation in September 2018. Updates to Caption Interpretation, which works with Guidance, also received 510(k) clearance in July 2020. The K243065 reference in the prompt is for a future date (01/15/2025) and details are not yet publicly available for this specific submission.

Integrations
EHR Not specified
Specialties Cardiology, Emergency Medicine, Radiology

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Press & Coverage

GE HealthCare
GE HealthCare Awarded a $44 Million Grant to Develop Artificial Intelligence-Assisted Ultrasound Technology Aimed at Improving Outcomes in Low-and-Middle-Income Countries
GE HealthCare's Caption Health division received a $44 million grant from the Bill & Melinda Gates Foundation to develop AI-assisted ultrasound tools for maternal, fetal, and pediatric lung health in low-and-middle-income countries. Caption Health currently offers FDA-cleared Cardiac Guidance software.
2023-09
Medimaging.net
AI-Assisted Ultrasound Technology to Improve Outcomes in Low-and-Middle-Income Countries
Caption Health, acquired by GE HealthCare, will lead the development of AI-powered ultrasound assessment tools for maternal, fetal, and pediatric lung health in low-and-middle-income countries, leveraging a grant from the Bill & Melinda Gates Foundation. The company's FDA-cleared Cardiac Guidance software is highlighted.
2023-09
Medical Device Network
GE HealthCare wins $44m grant to develop AI-assisted ultrasound tools
GE HealthCare's Caption Health division secured a $44 million grant from the Bill & Melinda Gates Foundation to create AI-assisted ultrasound auto-assessment tools, building on their FDA-approved Cardiac Guidance software developed with prior Gates Foundation funding in 2020.
2023-09
Lifestyles Magazine
$44 million from Gates to develop AI-assisted ultrasound technology
Caption Health, now part of GE HealthCare, received a significant grant from the Bill & Melinda Gates Foundation to expand its AI technology for lung and obstetric ultrasound, following its earlier success with FDA-cleared Cardiac Guidance software.
2023-09
Innolitics
Cardiac Guidance (K243065) u2014 FDA 510(k)
This entry details the FDA 510(k) clearance for Caption Health, Inc.'s Cardiac Guidance software (K243065), categorized under Radiology and cleared on January 15, 2025.
2025-01
accessdata.fda.gov
January 15, 2025 Caption Health, Inc. Tahir Rizvi Sr. Director of Regulatory Affairs 4 West 4th Avenue Suite 215 San Mateo, Cali
The FDA document confirms the substantial equivalence of Caption Health's Cardiac Guidance software, intended to assist medical professionals in acquiring cardiac ultrasound images, and outlines its indications for use in 2D transthoracic echocardiography for adult patients.
2025-01
ACEP
AI in POCUS: An Overview of the Current Billing and Reimbursement
Caption Health's AI-based Cardiac Guidance technology received NTAP approval in 2021, allowing for additional payment to facilities under specific ICD-10 diagnoses for cardiac POCUS image acquisition.
2026-02
GE HealthCare
Vscan Air SL with Caption AI - GE Healthcare
GE HealthCare highlights its Vscan Air SL with Caption AI, which includes Caption Guidance software for real-time, step-by-step assistance in acquiring diagnostic-quality cardiac ultrasound images and Caption Interpretation AutoEF for automated ejection fraction calculation.
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Suggest an Edit → | Last Verified: 2026-04-17 | First Added: 2026-04-17
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