Caption Guidance

by Caption Health  · Based in United States → — AI-guided cardiac ultrasound platform that enables non-specialists to acquire diagnostic-quality echo images.
Cardiology Critical Care Radiology

Regulatory Status Disclosed

Overview

Caption Guidance, a flagship product of Caption Health (acquired by GE HealthCare in February 2023), is the first FDA-cleared artificial intelligence (AI) software designed to assist medical professionals in acquiring diagnostic-quality cardiac ultrasound images. This innovative software acts as a ‘co-pilot’ for clinicians, including those without extensive sonography experience, by providing real-time, turn-by-turn guidance on how to manipulate the ultrasound transducer to achieve optimal cardiac views. It incorporates features like a Quality Meter that provides live feedback on image quality and an AutoCapture function that automatically saves the best diagnostic-quality clips. Integrated with compatible general-purpose diagnostic ultrasound systems, such as GE HealthCare’s Venue Family and Vscan Air SL, Caption Guidance aims to democratize access to high-quality echocardiograms, improve diagnostic accuracy, and reduce the need for repeat studies. It is particularly valuable in point-of-care settings like emergency departments, critical care units, and primary care clinics, and has also been instrumental in enabling in-home heart wellness assessments through the broader Caption AI platform.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Real-time AI guidance for ultrasound probe manipulation
  • Automated quality assessment with a 'Quality Meter'
  • Auto-capture of diagnostic-quality ultrasound clips
  • Automated ejection fraction calculation (as part of Caption AI/Interpretation)
  • Adjustable scanning protocols for up to 10 key cardiac views
  • Preliminary probe placement information
  • Real-time feedback on diagnostic image quality
  • Compatible with GE HealthCare Venue Family and Vscan Air SL ultrasound systems
  • Workflow scanning protocols for standard echocardiographic studies
  • DICOM export to PACS servers

Use Cases

  • Point-of-Care Ultrasound (POCUS) in acute settings
  • Emergency department cardiac assessments
  • Critical care unit patient monitoring
  • Anesthesiology department use
  • Primary care cardiac screening and assessment
  • In-home heart wellness assessments and mobile diagnostic services

What Physicians Need to Know

Echocardiography AI Features
Caption Guidance is an AI-powered software that provides real-time guidance for acquiring diagnostic-quality cardiac ultrasound images. It emulates the expertise of a sonographer by offering over 90 types of real-time instructions and feedback, including visual prompts for transducer movements. The system uses deep learning models trained on hundreds of thousands of echocardiographic images to recognize standard cardiac views in real-time. It continuously analyzes the live B-mode image stream against learned patterns for 10 standard echo views, such as parasternal long axis, apical four-chamber, and subcostal four-chamber. The software also features AutoCapture, which automatically records the optimal clip when image quality reaches a diagnostic threshold, and a quality meter that provides immediate visual confirmation of diagnostic image quality. Caption Guidance is designed to enable healthcare professionals, even those without extensive ultrasound experience, to perform cardiac assessments. When paired with Caption Interpretation, it can automatically calculate left ventricular ejection fraction (LVEF) from multiple views (PLAX, AP2, AP4).
Heart Failure Risk Prediction
Caption Guidance facilitates early detection of heart disease symptoms in at-risk patients, which can lead to timely interventions and potentially reduce hospitalizations. Cardiac ultrasound, which Caption Guidance assists with, is a primary tool for identifying heart failure. When used with Caption Interpretation, it produces reliable assessments of ejection fraction, which is a key measurement in assessing cardiac function across various cardiovascular conditions, including heart failure.
Real-Time Alert Capability
Caption Guidance provides real-time, turn-by-turn instructions and visual feedback to guide users in acquiring cardiac ultrasound images. This includes directional arrows and a quality meter on the screen. The system also features AutoCapture, which automatically captures a diagnostic-quality clip when the image quality meets the necessary criteria, and a 'Save Best Clip' function that allows users to retrospectively save the highest quality clip obtained during scanning.
Physician Tip

Caption Guidance can empower a broader range of healthcare professionals, including those without specialized sonography training, to acquire diagnostic-quality cardiac ultrasound images at the point of care. This can expedite cardiac assessments in settings like emergency departments and critical care units, potentially leading to faster triage and earlier interventions for conditions such as pericardial effusion, severe LV dysfunction, and right heart strain. The AI-driven guidance and auto-capture features can help standardize image acquisition and reduce variability in echocardiogram quality. While the software assists in image acquisition, a qualified medical professional must still interpret the images for final assessment and diagnosis.

Caption Guidance is integrated into GE HealthCare's Venue Family point-of-care ultrasound systems as an optional feature. GE HealthCare plans to incorporate this technology into additional ultrasound equipment, including handheld systems. It is also compatible with Terason uSmart 3200T ultrasound systems.

Details

Category Cardiology AI, Radiology & Imaging AI
Pricing Unknown
DeploymentOn-premise (integrated with ultrasound equipment) and cloud-based services.
Mobile AppYes
Training Yes
Compliance
BAA Available Yes AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Cleared AI-estimated
SOC 2 Yes AI-estimated
GDPR Yes AI-estimated
Integrations
EHR Not specified
Specialties Cardiology, Critical Care, Radiology

Support & Reliability

Training Provided Yes

What the Web Says

Caption Guidance, developed by Caption Health, is an AI-powered software designed to assist healthcare professionals in acquiring diagnostic-quality cardiac ultrasound images. It provides real-time instructions and feedback, enabling even those without extensive sonography experience, such as registered nurses, to perform echocardiograms effectively. The software has received multiple FDA clearances, including an expedited review during the COVID-19 pandemic to help frontline workers, and studies have shown high agreement between images captured with Caption Guidance by nurses and those by expert sonographers.

Overall: Positive

Strengths

  • Enables healthcare professionals without prior ultrasound experience to acquire diagnostic-quality cardiac ultrasound images.
  • Provides real-time instructions and feedback, including visual prompts for transducer movements.
  • Continuously assesses and records images, offering real-time feedback on image quality.
  • Automates the selection of best clips and calculates ejection fraction (EF) for cardiac function assessment.
  • Received expedited FDA clearance to assist frontline healthcare workers during the COVID-19 pandemic.
  • Studies demonstrate high agreement between scans performed by nurses using Caption Guidance and those by expert sonographers.

Limitations

  • Currently, there is no additional reimbursement for the use of AI in most clinical scenarios, though this may change.
  • AI systems function as assistive technologies and still require physician review for final assessment.
  • Handheld ultrasound machines, which Caption Guidance can be used with, may be limited in features compared to conventional machines.
  • The software currently works with a specific FDA-cleared diagnostic ultrasound system, though it has the potential for broader compatibility.

Based on reviews from: nanalyze.com, sourceforge.net, dicardiology.com, nih.gov, spandidos-publications.com, itnonline.com, acep.org, biospace.com, massdevice.com, healthcareweekly.com, indeed.com, bioworld.com, aionlinecourse.com, slashdot.org, researchgate.net, tomwademd.net, arxiv.org, tapvid.ai, ybug.io, scribd.com, brownemblog.com

Last updated: 2026-10-29

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Press & Coverage

gehealthcare.com
GE HealthCare to Acquire Caption Health, Expanding Ultrasound to Support New Users Through FDA-Cleared, AI-Powered Image Guidance
GE HealthCare announced its agreement to acquire Caption Health, an AI healthcare leader, to expand access to ultrasound imaging for early disease detection. The acquisition aims to integrate Caption Health's AI applications, including Caption Guidance, into GE HealthCare's ultrasound portfolio, enabling more healthcare professionals to perform basic echocardiogram exams.
2023-02
appliedradiology.com
GE HealthCare Adds AI-Driven, Real-Time Guidance to Ultrasound Systems
GE HealthCare introduced Caption Guidance, an AI-driven technology providing real-time guidance for capturing diagnostic-quality cardiac images, to its Venue Family point-of-care ultrasound systems. This integration follows GE HealthCare's acquisition of Caption Health and aims to expand ultrasound access by supporting clinicians in various settings, including emergency departments and critical care.
2023-10
massdevice.com
GE HealthCare Launches Venue Family Point-of-Care Ultrasound Systems with AI-Driven Caption Guidance
GE HealthCare launched its Venue point-of-care ultrasound systems with AI-driven Caption Guidance, an optional add-on that offers new capabilities for diagnostic-quality cardiac images. This integration, a result of the Caption Health acquisition, provides step-by-step instructions to clinicians, addressing training barriers and expanding ultrasound access for early detection of heart disease.
2023-10
prnewswire.com
Caption Health Receives Regulatory Approvals for Caption AI™ Technology Platform in Canada and Australia
Caption Health announced regulatory approvals from Health Canada and Australia's Therapeutic Goods Administration for its Caption AI™ technology platform. These approvals mark the second and third international regulatory clearances for Caption AI in 2022, following a European CE Mark, enabling the platform to be marketed in these regions.
2022-11
prnewswire.com
Caption Health Receives CE Mark for Caption AI™ technology platform
Caption Health received a CE Mark for its Caption AI™ technology platform, signifying its compliance with European health, safety, and environmental protection standards. This regulatory milestone allows Caption Health to market its AI-powered ultrasound guidance and interpretation technology in the European Union.
2022-07
mobihealthnews.com
AI-assisted cardiac ultrasound guidance software receives De Novo clearance
Caption Health's AI-assisted cardiac ultrasound guidance software received De Novo clearance from the FDA in February 2020. This clearance allows non-expert medical staff to produce high-quality diagnostic images in real time, addressing the challenge of specialized training required for ultrasound.
2020-02
dcvc.com
Caption Health Secures FDA Authorization for First-in-Class AI-Guided Medical Ultrasound
Caption Health received De Novo FDA authorization for Caption Guidance, its AI-powered ultrasound product, under the Breakthrough Device program. This authorization allows healthcare professionals without prior ultrasound experience to capture diagnostic-quality cardiac images, aiming to increase access to timely care.
2020-02
massdevice.com
FDA authorizes use of Caption Health's AI software to capture heart images via ultrasound
The FDA authorized the marketing of Caption Health's Caption Guidance software, an accessory to compatible diagnostic ultrasound systems, to assist medical professionals in acquiring cardiac ultrasound images. The software uses AI to help capture diagnostic-quality images of a patient's heart, enabling non-expert ultrasonographers, such as registered nurses, to utilize diagnostic ultrasound.
2020-02

Videos

Product demos, reviews, and walkthroughs for Caption Guidance.

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Frequently Asked Questions

Caption Guidance is an AI-powered software designed to assist medical professionals, including cardiologists, in acquiring high-quality cardiac ultrasound images. It provides real-time, turn-by-turn guidance for probe positioning and offers automated feedback on diagnostic image quality, effectively acting as a "co-pilot" during ultrasound exams.
Yes, Caption Guidance received FDA marketing authorization via the De Novo pathway in February 2020. This designation is for novel technologies that provide more effective treatment or diagnosis and have no approved alternatives, indicating its compliance with regulatory standards for medical software. Users are responsible for image quality and diagnosis, and images acquired with Caption Guidance must be interpreted by qualified medical professionals.
Caption Guidance was authorized by the FDA as a breakthrough technology with no approved alternatives at the time of its De Novo authorization. It is unique in its ability to provide real-time AI guidance for cardiac ultrasound image acquisition, empowering even those without prior extensive ultrasound experience to capture diagnostic-quality images.
Specific enterprise pricing for Caption Guidance is not publicly published, and interested parties are typically advised to contact sales for a quote. However, the Caption AI offering, which includes Caption Guidance and Caption Interpretation, is available as a one-time payment for the life of the probe when paired with compatible GE HealthCare Vscan Air SL devices.
While Caption Guidance significantly aids in image acquisition, it is indicated for use in two-dimensional transthoracic echocardiography (2D-TTE) for adult patients and specifically for acquiring standard views of the heart. Product users remain responsible for the final image quality and diagnosis, and images must be interpreted by qualified medical professionals. The software's cardiology-specific features may be limited to general templates, and its enterprise pricing is not publicly disclosed.
Caption Guidance software can be integrated onto compatible ultrasound devices. It is an accessory to compatible general purpose diagnostic ultrasound systems. While information on direct EHR integration for Caption Guidance specifically is not detailed, other AI scribe tools from different companies may offer bidirectional EHR integration.
Caption Guidance uses deep learning models trained on hundreds of thousands of echocardiographic images to recognize standard cardiac views in real-time. It provides real-time instructions on how to manipulate the transducer and offers automated feedback on diagnostic image quality, including a quality meter on screen. The system can also auto-capture optimal clips when diagnostic quality is reached, reducing the chance of suboptimal images.

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