Cardiac Guidance

by Caption Health  · Based in United States → — AI leader that provides heart ultrasound access for early disease detection
Cardiology Emergency Medicine Radiology

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

Echocardiography AI Features
Caption Guidance provides real-time AI guidance for cardiac ultrasound image acquisition, assisting users in obtaining diagnostic-quality images. It offers turn-by-turn probe positioning instructions, a quality meter for optimal image capture, and features like AutoCapture and Save Best Clip. The software guides users to acquire 10 standard echocardiographic views, including parasternal long-axis, parasternal short-axis, and apical views. Caption Interpretation, part of the Caption AI platform, automatically calculates left ventricular ejection fraction (LVEF) from multiple views (PLAX, AP2, AP4). This automated EF calculation analyzes every pixel and frame in a given clip for accuracy. The system is designed to enable medical professionals without specialized ultrasound training to perform cardiac assessments.
Heart Failure Risk Prediction
Caption Health's technology aims to improve early detection and management of heart failure by making cardiac ultrasounds more accessible. The ability to perform quick and accurate assessments of cardiac function, including ejection fraction, is crucial for identifying and managing heart failure. Partnerships have been formed to integrate AI-guided echocardiograms with virtual cardiology care to facilitate early disease identification and management, even in patients' homes.
Real-Time Alert Capability
The software provides real-time visual guidance for probe movements and a quality meter to ensure optimal image capture. It offers immediate visual confirmation that the current image meets diagnostic criteria, reducing guesswork. Caption Guidance also features AutoCapture, which automatically records the optimal clip when image quality reaches a diagnostic threshold, eliminating the need for manual intervention at the precise moment.
Physician Tip

Caption Guidance can empower a wider range of healthcare professionals, including those without extensive sonography experience, to acquire diagnostic-quality cardiac ultrasound images at the point of care. This can lead to faster clinical decisions, especially in acute settings like emergency departments and ICUs, by enabling immediate focused cardiac assessments. The automated ejection fraction calculation (AutoEF) can provide quick and reliable assessments of cardiac function, aiding in the diagnosis and monitoring of conditions like heart failure. While the AI assists in image acquisition and initial interpretation, final assessment and diagnosis should still be performed by a cardiologist.

Caption AI is integrated with GE HealthCare's ultrasound systems, including the Vscan Air SL handheld ultrasound and the Venue Family point-of-care ultrasound systems. It is designed to be compatible with multiple ultrasound vendors. The software has also been part of collaborations with other platforms, such as Butterfly Network's handheld ultrasound devices and Ultromics' EchoGo deep ultrasound analytics.

Details

Category Cardiology AI, Radiology & Imaging AI
Pricing Unknown
DeploymentCaption Guidance is deployed in acute point-of-care settings, including emergency and anesthesiology departments and critical care units. It is also used in doctors' offices and can be used for at-home care.
API AvailableUnknown
TrainingUnknown
Compliance
BAA AvailableUnknown
HIPAA CompliantUnknown
FDA Status Cleared AI-estimated
Integrations
EHR Not specified
Specialties Cardiology, Emergency Medicine, Radiology

Support & Reliability

Training ProvidedUnknown

What the Web Says

Caption Health's "Cardiac Guidance" is an AI-powered software designed to assist clinicians in acquiring and interpreting cardiac ultrasound images in real-time. It aims to improve image quality and consistency, reduce variability in echocardiography, and help both experienced and less-experienced operators obtain diagnostic-quality cardiac images efficiently. The technology has received FDA 510(k) clearance and is integrated into GE HealthCare's ultrasound systems following GE HealthCare's acquisition of Caption Health in February 2023.

Overall: Positive

Strengths

  • Improves image quality and consistency in cardiac ultrasound.
  • Assists both experienced and less-experienced operators in image acquisition and analysis.
  • Reduces variability in echocardiography.
  • Helps ensure diagnostic-quality cardiac images are obtained efficiently.
  • Provides real-time guidance during scans, optimizing probe positioning and image acquisition.
  • Can democratize access to advanced ultrasound imaging and improve patient outcomes.

Limitations

  • AI-only interpretation of POCUS studies without physician review is not currently reimbursed.
  • Reimbursement for AI in most clinical scenarios is not additional, though this may change.
  • Some ultrasound products may require mandatory cloud services for full functionality.
  • Yearly software updates for some ultrasound systems can be costly and may not offer significant new features.

Based on reviews from: physicianaitools.com, reachmd.com, gehealthcare.com, vscan.rocks, publicnow.com, wipo.int, acep.org, healthcareaiops.com, innolitics.com, rsna.org, mpo-mag.com

Last updated: 2026-10-29

Ratings & Reviews

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Press & Coverage

medicaldevice-network.com
GE HealthCare's Vscan Air SL integrates Caption AI-driven Cardiac Guidance
GE HealthCare's Vscan Air SL now features Caption AI-driven Cardiac Guidance and Interpretation software, offering real-time, step-by-step instructions for acquiring high-quality echocardiographic views and automatically calculating left ventricular ejection fraction. This integration aims to help clinicians rapidly assess cardiac functions at the point of care.
2024-06
businesswire.com
GE HealthCare Awarded $44M Grant to Develop AI-Assisted Ultrasound Tech
GE HealthCare received a $44 million grant from the Bill & Melinda Gates Foundation to develop AI-assisted ultrasound imaging tools, with Caption Health designing the technology. This initiative aims to expand access to user-friendly ultrasound for obstetric and lung screening, building on Caption Health's existing FDA-cleared Cardiac Guidance software.
2023-09
healthcareaiops.com
FDA 510(k) K243065: Cardiac Guidance by Caption Health, Inc., cleared 2025-01-15 under AI-associated product code QJU
Caption Health's Cardiac Guidance software received FDA 510(k) clearance on January 15, 2025, under product code QJU. This regulatory approval highlights the continued advancement and acceptance of AI-powered tools in medical imaging.
2025-01
wipo.int
Case Study: Caption Health
This case study details GE HealthCare's acquisition of Caption Health in February 2023, integrating Caption AI into its ultrasound systems. It emphasizes how regulatory clearance, including FDA 510(k) for Cardiac Guidance, significantly enhances the value of AI-driven medical technology.
2023-02
reachmd.com
FDA-Cleared AI Medical Device Tracker
Caption Health's Cardiac Guidance uses AI to assist clinicians in acquiring and interpreting cardiac ultrasound images in real-time, aiming to improve image quality and consistency. This device helps both experienced and less-experienced operators by providing guidance during image acquisition and analysis support.
2026-05
gehealthcare.com
AI-guided ultrasound: The future of diagnostic imaging
AI-guided ultrasound, such as Caption cardiac guidance on Vscan Air SL, is transforming healthcare by making diagnostic-quality imaging more accessible. This technology provides real-time, step-by-step feedback to users, reducing the skill barrier in ultrasound and enabling consistent, high-quality imaging.
2025-01
vscan.rocks
Vscan Air™ SL
The Vscan Air SL is highlighted for its suitability in cardiology, with Caption AI™ optionally complementing cardiac diagnostics by providing real-time probe guidance and automatic ejection fraction calculation. This AI-powered solution aims to help clinicians make confident decisions at the point of care.
2025-12

Videos

Product demos, reviews, and walkthroughs for Cardiac Guidance.

View all on YouTube

Frequently Asked Questions

Caption Guidance is an FDA-cleared AI software that acts as a "co-pilot" for clinicians during cardiac ultrasound examinations. It provides real-time, turn-by-turn probe positioning instructions and automated feedback on diagnostic image quality, enabling even non-specialist physicians to acquire diagnostic-quality cardiac ultrasound images.
Caption Guidance received FDA 510(k) clearance in February 2020 and was authorized via the De Novo pathway, a regulatory path for novel technologies. It was also granted Breakthrough Device designation by the FDA in 2018. The software is indicated for use in two-dimensional transthoracic echocardiography (2D-TTE) for adult patients to acquire standard cardiac views.
While Caption Guidance assists in acquiring diagnostic-quality images, a cardiologist is still required to review the images and videos for the final patient evaluation and diagnosis. The software is designed as an assistive tool and users are responsible for image quality and diagnosis.
While Caption Guidance was the first medical software authorized by the FDA to provide real-time AI guidance for medical imaging acquisition, other companies are also developing AI-enabled ultrasound solutions. Some alternatives in the broader AI and automation category for cardiology include Intelligent Ultrasound, INFINITT Cardiology Suite, Verisound AI, and Clarius.
Caption Guidance aims to close the skills gap in cardiac ultrasound, allowing healthcare providers without extensive sonography training, such as emergency physicians, hospitalists, and nurses, to perform limited cardiac assessments. This can lead to faster triage for conditions like pericardial effusion, severe LV dysfunction, and right heart strain, and reduce delays in clinical decisions by enabling point-of-care cardiac assessments without waiting for a formal echo.
Specific pricing for Caption Guidance is not publicly available, but it is noted that hospitals may be eligible for additional payments through New Technology Add-on Payments (NTAP) for Medicare patients receiving inpatient care. These payments can be significant in cases where the costs of using the technology exceed the payment under the corresponding Diagnostic Related Group (DRG). Pricing information can be requested directly from GE HealthCare.

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Suggest an Edit → | Report an issue | Last Verified: 2026-04-17 | First Added: 2026-04-17
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