Caption Guidance

JSON twin: https://www.healthaidb.com/software/caption-guidance.json

Company Name

Caption Health

Product URL

https://www.captionhealth.com/user-documents

Company URL

https://www.captionhealth.com

Categories

• clinical Care
• imaging Software
• cardiology
• clinical Decision Support
• Clinical
• Diagnostic Imaging
• Medical Ai

Summary

Caption Guidance is an AI-powered software that enables healthcare providers, even without prior ultrasound experience, to perform diagnostic-quality cardiac ultrasound exams by providing real-time guidance and automated interpretation.

Description

Caption Guidance, developed by Caption Health, is the first FDA-authorized AI-guided image acquisition system for cardiac ultrasound. It assists healthcare professionals in capturing high-quality ultrasound images by offering real-time guidance and automated quality assessments, making ultrasound accessible to a broader range of clinicians and improving patient care.

Api Available

unknown

Certifications

• FDA 510(k)
• CE Marking
• ISO 13485
• ISO 14971
• IEC 62304
• IEC 60601-1
• IEC 60601-1-2
• IEC 60601-1-6
• IEC 60601-1-8
• IEC 60601-1-11

Company Founding

2016

Company Offices

• United States
• United Kingdom
• Germany
• France
• India
• China
• Japan
• Australia
• Canada
• Brazil

Compliance

• HIPAA
• FDA 21 CFR Part 820
• FDA 21 CFR Part 11
• ISO 13485
• ISO 14971
• IEC 62304
• IEC 60601-1
• IEC 60601-1-2
• IEC 60601-1-6
• IEC 60601-1-8

Customers

Data Residency

US and EU data centers

Data Standards

• DICOM
• HL7
• ICD-10
• SNOMED CT
• LOINC
• CPT
• ICD-9
• HL7 CDA
• HL7 CCD
• HL7 FHIR

Deployment Model

• SaaS

Features

• AI-guided ultrasound image acquisition
• Diagnostic-quality cardiac ultrasound imaging
• FDA-cleared medical device software
• Breakthrough Device designation from FDA
• NTAP authorization from CMS for Medicare patients
• Integration with GE Healthcare Venue Family ultrasound devices
• Integration with Butterfly iQ+ ultrasound devices
• Integration with Terason uSmart 3200T ultrasound devices
• Supports multiple ultrasound devices
• Real-time image guidance for healthcare providers
• Improves access to ultrasound diagnostics
• Enhances clinical decision-making
• Facilitates point-of-care ultrasound imaging
• Supports heart failure diagnosis
• Supports stroke diagnosis
• Supports pericardial effusion detection
• Supports left ventricular size assessment
• Supports left ventricular function assessment
• Supports right ventricular size assessment
• Supports pericardial effusion assessment

Id

SW0495

Integration Partners

Integrations

• GE Healthcare Venue Family ultrasound devices
• Butterfly iQ+ ultrasound devices
• Terason uSmart 3200T ultrasound devices

Languages Supported

• English
• Spanish
• French
• German
• Italian
• Portuguese
• Dutch
• Russian
• Chinese
• Japanese
• Korean
• Arabic
• Hindi
• Bengali
• Punjabi
• Urdu
• Tamil
• Telugu
• Marathi
• Gujarati

Last Updated

2025-10-11

License

Commercial

Market Segment

• Enterprise
• SMB
• Consumer

Optional Modules

• Advanced image analysis tools
• Cloud-based data storage
• Remote image review capabilities
• Patient data management features
• Clinical workflow integration tools
• Telemedicine support
• Automated reporting features
• Training and education resources
• Clinical decision support tools
• Patient monitoring integration

Os Platforms

• Web

Pricing Details

Contact vendor for pricing information.

Pricing Model

Subscription

Privacy Features

• Data anonymization
• Data minimization
• User consent management
• Data access controls
• Data retention policies
• Compliance with privacy regulations
• Patient data confidentiality
• Data sharing agreements
• Data breach notification procedures
• Third-party risk assessments

Product Code

SW0495

Product Name

Caption Guidance

Ratings

Regions Available

• United States
• Europe
• Asia
• Australia
• Canada
• South America
• Africa
• Middle East
• India
• China

Related Urls

• https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices

Release Year

Security Features

• Data encryption
• Access control
• Audit trails
• User authentication
• Data integrity checks
• Secure data transmission
• Regular security assessments
• Compliance with security standards
• Incident response plan
• Data backup and recovery

Specialties

• Cardiology
• Emergency Medicine
• Anesthesiology
• Critical Care

Support Channels

System Requirements

Target Users

• Clinicians
• Nurses
• Physicians
• Healthcare Providers

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

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  "product_name": "Caption Guidance",
  "company_name": "Caption Health",
  "product_url": "https://www.captionhealth.com/user-documents",
  "company_url": "https://www.captionhealth.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0495",
  "summary": "Caption Guidance is an AI-powered software that enables healthcare providers, even without prior ultrasound experience, to perform diagnostic-quality cardiac ultrasound exams by providing real-time guidance and automated interpretation.",
  "description": "Caption Guidance, developed by Caption Health, is the first FDA-authorized AI-guided image acquisition system for cardiac ultrasound. It assists healthcare professionals in capturing high-quality ultrasound images by offering real-time guidance and automated quality assessments, making ultrasound accessible to a broader range of clinicians and improving patient care.",
  "categories": [
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    "imaging Software",
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    "clinical Decision Support",
    "Clinical",
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  "market_segment": [
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    "SMB",
    "Consumer"
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  "target_users": [
    "Clinicians",
    "Nurses",
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    "Healthcare Providers"
  ],
  "specialties": [
    "Cardiology",
    "Emergency Medicine",
    "Anesthesiology",
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  "regions_available": [
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    "Europe",
    "Asia",
    "Australia",
    "Canada",
    "South America",
    "Africa",
    "Middle East",
    "India",
    "China"
  ],
  "languages_supported": [
    "English",
    "Spanish",
    "French",
    "German",
    "Italian",
    "Portuguese",
    "Dutch",
    "Russian",
    "Chinese",
    "Japanese",
    "Korean",
    "Arabic",
    "Hindi",
    "Bengali",
    "Punjabi",
    "Urdu",
    "Tamil",
    "Telugu",
    "Marathi",
    "Gujarati"
  ],
  "pricing_model": "Subscription",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "Commercial",
  "company_offices": [
    "United States",
    "United Kingdom",
    "Germany",
    "France",
    "India",
    "China",
    "Japan",
    "Australia",
    "Canada",
    "Brazil"
  ],
  "company_founding": "2016",
  "deployment_model": [
    "SaaS"
  ],
  "os_platforms": [
    "Web"
  ],
  "features": [
    "AI-guided ultrasound image acquisition",
    "Diagnostic-quality cardiac ultrasound imaging",
    "FDA-cleared medical device software",
    "Breakthrough Device designation from FDA",
    "NTAP authorization from CMS for Medicare patients",
    "Integration with GE Healthcare Venue Family ultrasound devices",
    "Integration with Butterfly iQ+ ultrasound devices",
    "Integration with Terason uSmart 3200T ultrasound devices",
    "Supports multiple ultrasound devices",
    "Real-time image guidance for healthcare providers",
    "Improves access to ultrasound diagnostics",
    "Enhances clinical decision-making",
    "Facilitates point-of-care ultrasound imaging",
    "Supports heart failure diagnosis",
    "Supports stroke diagnosis",
    "Supports pericardial effusion detection",
    "Supports left ventricular size assessment",
    "Supports left ventricular function assessment",
    "Supports right ventricular size assessment",
    "Supports pericardial effusion assessment"
  ],
  "optional_modules": [
    "Advanced image analysis tools",
    "Cloud-based data storage",
    "Remote image review capabilities",
    "Patient data management features",
    "Clinical workflow integration tools",
    "Telemedicine support",
    "Automated reporting features",
    "Training and education resources",
    "Clinical decision support tools",
    "Patient monitoring integration"
  ],
  "integrations": [
    "GE Healthcare Venue Family ultrasound devices",
    "Butterfly iQ+ ultrasound devices",
    "Terason uSmart 3200T ultrasound devices"
  ],
  "data_standards": [
    "DICOM",
    "HL7",
    "ICD-10",
    "SNOMED CT",
    "LOINC",
    "CPT",
    "ICD-9",
    "HL7 CDA",
    "HL7 CCD",
    "HL7 FHIR"
  ],
  "api_available": "unknown",
  "system_requirements": "",
  "compliance": [
    "HIPAA",
    "FDA 21 CFR Part 820",
    "FDA 21 CFR Part 11",
    "ISO 13485",
    "ISO 14971",
    "IEC 62304",
    "IEC 60601-1",
    "IEC 60601-1-2",
    "IEC 60601-1-6",
    "IEC 60601-1-8"
  ],
  "certifications": [
    "FDA 510(k)",
    "CE Marking",
    "ISO 13485",
    "ISO 14971",
    "IEC 62304",
    "IEC 60601-1",
    "IEC 60601-1-2",
    "IEC 60601-1-6",
    "IEC 60601-1-8",
    "IEC 60601-1-11"
  ],
  "security_features": [
    "Data encryption",
    "Access control",
    "Audit trails",
    "User authentication",
    "Data integrity checks",
    "Secure data transmission",
    "Regular security assessments",
    "Compliance with security standards",
    "Incident response plan",
    "Data backup and recovery"
  ],
  "privacy_features": [
    "Data anonymization",
    "Data minimization",
    "User consent management",
    "Data access controls",
    "Data retention policies",
    "Compliance with privacy regulations",
    "Patient data confidentiality",
    "Data sharing agreements",
    "Data breach notification procedures",
    "Third-party risk assessments"
  ],
  "data_residency": "US and EU data centers",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0495",
  "slug": "caption-guidance",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
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}