Fetal EchoScan

JSON twin: https://www.healthaidb.com/software/fetal-echoscan.json

Company Name

BrightHeart

Product URL

https://brightheart.com/fetal-echoscan

Company URL

https://brightheart.com

Categories

• clinical Care
• diagnostic Support
• patient Facing
• Clinical
• Diagnostic

Summary

Fetal EchoScan is an AI-powered software by BrightHeart that enhances prenatal ultrasound evaluations by automating the detection of standard fetal heart views and identifying signs suggestive of congenital heart defects (CHDs).

Description

Fetal EchoScan is an artificial intelligence (AI) software developed by BrightHeart to improve the accuracy and efficiency of prenatal fetal heart ultrasound evaluations. It automates the detection of standard fetal heart views and identifies morphological signs indicative of severe congenital heart defects (CHDs), thereby assisting clinicians in early detection and intervention. The software seamlessly integrates into existing ultrasound workflows, providing real-time feedback without the need for additional tools or software. It processes ultrasound images in standard DICOM format, ensuring compatibility with existing systems and facilitating rapid analysis with results available within minutes. BrightHeart's AI models were developed with over 50,000 ultrasound studies to accurately detect key morphological signs suggestive of CHD, including overriding artery, abnormal relationship of the outflow tracts, cardiac axis deviation, RV/LV size discrepancy, septal defect at the cardiac crux, TV/MV size discrepancy, enlarged cardiothoracic ratio, and PV/AV size discrepancy. The software has received FDA 510(k) clearance, marking a significant advancement in prenatal care by providing clinicians with a comprehensive tool to enhance fetal heart evaluations and improve outcomes for expectant families.

Api Available

unknown

Certifications

• FDA 510(k) clearance
• ISO 27001 certification

Company Founding

2023

Company Offices

• France
• United States

Compliance

• HIPAA
• FDA 510(k) clearance
• ISO 27001 certification

Customers

Data Residency

On-site pseudonymization with no PHI sent to BrightHeart cloud

Data Standards

• DICOM

Deployment Model

• SaaS
• on_prem
• hybrid

Features

• Automated detection of standard views for second and third-trimester fetal heart ultrasound evaluations
• Real-time feedback on fetal heart documentation
• Flagging of structural markers suggestive of congenital heart defects (CHDs)
• Seamless integration into existing ultrasound workflows
• Compatibility with standard DICOM format
• On-site pseudonymization with no PHI sent to BrightHeart cloud
• Intuitive reporting highlighting standard views and signs suspicious for CHDs
• Fast processing with results available within minutes

Id

SW0031

Integration Partners

Integrations

• Ultrasound machines
• PACS systems
• Reporting software

Languages Supported

• English
• French

Last Updated

2025-10-11

License

Commercial

Market Segment

• Enterprise
• SMB

Optional Modules

• B-Right Views
• B-Right Screen AI

Os Platforms

• Web
• iOS
• Android
• Windows
• macOS
• Linux

Pricing Details

Contact vendor for pricing information.

Pricing Model

Subscription

Privacy Features

• Data sharing only with explicit user consent
• No PHI sent to BrightHeart cloud

Product Code

SW0031

Product Name

Fetal EchoScan

Ratings

Regions Available

• United States
• Europe
• North Africa

Related Urls

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

Release Year

Security Features

• End-to-end encryption (AES-256)
• Secure cloud infrastructure
• Regular security audits
• Multi-factor authentication (MFA)
• On-site pseudonymization

Specialties

• Obstetrics
• Pediatric Cardiology

Support Channels

System Requirements

Standard ultrasound machines, PACS systems, reporting software

Target Users

• Clinicians
• Sonographers
• OB-GYNs
• Maternal-Fetal Medicine Specialists

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "Fetal EchoScan",
  "company_name": "BrightHeart",
  "product_url": "https://brightheart.com/fetal-echoscan",
  "company_url": "https://brightheart.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0031",
  "summary": "Fetal EchoScan is an AI-powered software by BrightHeart that enhances prenatal ultrasound evaluations by automating the detection of standard fetal heart views and identifying signs suggestive of congenital heart defects (CHDs).",
  "description": "Fetal EchoScan is an artificial intelligence (AI) software developed by BrightHeart to improve the accuracy and efficiency of prenatal fetal heart ultrasound evaluations. It automates the detection of standard fetal heart views and identifies morphological signs indicative of severe congenital heart defects (CHDs), thereby assisting clinicians in early detection and intervention. The software seamlessly integrates into existing ultrasound workflows, providing real-time feedback without the need for additional tools or software. It processes ultrasound images in standard DICOM format, ensuring compatibility with existing systems and facilitating rapid analysis with results available within minutes. BrightHeart's AI models were developed with over 50,000 ultrasound studies to accurately detect key morphological signs suggestive of CHD, including overriding artery, abnormal relationship of the outflow tracts, cardiac axis deviation, RV/LV size discrepancy, septal defect at the cardiac crux, TV/MV size discrepancy, enlarged cardiothoracic ratio, and PV/AV size discrepancy. The software has received FDA 510(k) clearance, marking a significant advancement in prenatal care by providing clinicians with a comprehensive tool to enhance fetal heart evaluations and improve outcomes for expectant families.",
  "categories": [
    "clinical Care",
    "diagnostic Support",
    "patient Facing",
    "Clinical",
    "Diagnostic",
    "Patient-facing"
  ],
  "market_segment": [
    "Enterprise",
    "SMB"
  ],
  "target_users": [
    "Clinicians",
    "Sonographers",
    "OB-GYNs",
    "Maternal-Fetal Medicine Specialists"
  ],
  "specialties": [
    "Obstetrics",
    "Pediatric Cardiology"
  ],
  "regions_available": [
    "United States",
    "Europe",
    "North Africa"
  ],
  "languages_supported": [
    "English",
    "French"
  ],
  "pricing_model": "Subscription",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "Commercial",
  "company_offices": [
    "France",
    "United States"
  ],
  "company_founding": "2023",
  "deployment_model": [
    "SaaS",
    "on_prem",
    "hybrid"
  ],
  "os_platforms": [
    "Web",
    "iOS",
    "Android",
    "Windows",
    "macOS",
    "Linux"
  ],
  "features": [
    "Automated detection of standard views for second and third-trimester fetal heart ultrasound evaluations",
    "Real-time feedback on fetal heart documentation",
    "Flagging of structural markers suggestive of congenital heart defects (CHDs)",
    "Seamless integration into existing ultrasound workflows",
    "Compatibility with standard DICOM format",
    "On-site pseudonymization with no PHI sent to BrightHeart cloud",
    "Intuitive reporting highlighting standard views and signs suspicious for CHDs",
    "Fast processing with results available within minutes"
  ],
  "optional_modules": [
    "B-Right Views",
    "B-Right Screen AI"
  ],
  "integrations": [
    "Ultrasound machines",
    "PACS systems",
    "Reporting software"
  ],
  "data_standards": [
    "DICOM"
  ],
  "api_available": "unknown",
  "system_requirements": "Standard ultrasound machines, PACS systems, reporting software",
  "compliance": [
    "HIPAA",
    "FDA 510(k) clearance",
    "ISO 27001 certification"
  ],
  "certifications": [
    "FDA 510(k) clearance",
    "ISO 27001 certification"
  ],
  "security_features": [
    "End-to-end encryption (AES-256)",
    "Secure cloud infrastructure",
    "Regular security audits",
    "Multi-factor authentication (MFA)",
    "On-site pseudonymization"
  ],
  "privacy_features": [
    "Data sharing only with explicit user consent",
    "No PHI sent to BrightHeart cloud"
  ],
  "data_residency": "On-site pseudonymization with no PHI sent to BrightHeart cloud",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0031",
  "slug": "fetal-echoscan",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/fetal-echoscan.json"
  }
}