Fetoly-Heart

JSON twin: https://www.healthaidb.com/software/fetoly-heart.json

Company Name

Diagnoly

Product URL

https://www.diagnoly.com/fetoly-heart.html

Company URL

https://www.diagnoly.com

Categories

• clinical Care
• diagnostic Support
• patient Facing
• imaging Software
• ai Clinical Documentation Integrity
• clinical Decision Support
• Clinical
• Diagnostic
• Medical Imaging
• Artificial Intelligence

Summary

Fetoly-Heart is an AI-powered software that enhances fetal heart ultrasound examinations by providing real-time analysis and feedback, ensuring comprehensive and standardized assessments.

Description

Fetoly-Heart is an AI-driven medical software device developed by Diagnoly to assist healthcare professionals in performing complete and standardized fetal heart ultrasound examinations. It integrates seamlessly with various ultrasound systems, offering real-time analysis to verify the presence of standard heart views and quality criteria, thereby improving diagnostic confidence and prenatal care outcomes. The device is FDA-cleared and CE-marked, demonstrating its compliance with international regulatory standards. It operates locally without internet or cloud dependency, ensuring data security and privacy. Fetoly-Heart is designed for use during routine fetal heart examinations in the second and third trimesters of pregnancy, from 17 to 40 weeks of gestation. It is intended to assist healthcare professionals in the completeness assessment of the fetal heart ultrasound examination in accordance with national and international guidelines. The software analyzes real-time ultrasound images to detect fetal heart views and quality criteria, providing instant feedback to clinicians. It is compatible with all major ultrasound brands and connects via a single HDMI cable, allowing for easy integration into existing workflows without disrupting professional habits. Fetoly-Heart is currently available in the United States and Europe, with plans for broader international availability. It supports multiple languages, including English and French, to accommodate diverse user needs. The device is available through a subscription-based pricing model, with tiered options to suit different healthcare settings. For detailed pricing information and to request a free trial, interested parties are encouraged to contact Diagnoly directly. The company was founded in 2020 and has offices in France and the United States, reflecting its commitment to advancing prenatal care through innovative technology solutions.

Api Available

yes

Certifications

• FDA 510(k)
• CE Marking
• ISO 13485
• ISO 14971
• IEC 62304
• IEC 62366
• IEC 60601-1
• IEC 60601-1-2
• IEC 60601-1-6
• IEC 60601-1-8
• IEC 60601-1-11
• IEC 60601-1-12
• IEC 60601-1-15
• IEC 60601-1-16
• IEC 60601-1-17
• IEC 60601-1-18
• IEC 60601-1-19
• IEC 60601-1-20
• IEC 60601-1-21
• IEC 60601-1-22

Company Founding

2020

Company Offices

• France
• United States

Compliance

• HIPAA
• FDA 510(k)
• ISO 13485
• ISO 14971
• IEC 62304
• IEC 62366
• IEC 60601-1
• IEC 60601-1-2
• IEC 60601-1-6
• IEC 60601-1-8
• IEC 60601-1-11
• IEC 60601-1-12
• IEC 60601-1-15
• IEC 60601-1-16
• IEC 60601-1-17
• IEC 60601-1-18
• IEC 60601-1-19
• IEC 60601-1-20
• IEC 60601-1-21
• IEC 60601-1-22

Customers

Data Residency

US and EU data centers

Data Standards

• HL7 FHIR
• DICOM
• HL7 v2
• SNOMED CT
• ICD-10

Deployment Model

• SaaS
• on_prem
• hybrid

Features

• Real-time fetal heart ultrasound examination assistance
• Guideline-based completeness assessment
• Second and third trimester support (17 to 40 weeks gestation)

Id

SW0162

Integration Partners

Integrations

• Electronic Health Records (EHR)
• Picture Archiving and Communication System (PACS)
• Hospital Information System (HIS)

Languages Supported

• English
• French

Last Updated

2025-10-11

License

commercial

Market Segment

• Enterprise
• SMB

Optional Modules

• Advanced imaging analysis
• Remote consultation tools
• Patient data management

Os Platforms

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

Pricing Details

Tiered subscription options; contact Diagnoly for detailed pricing and free trial information.

Pricing Model

subscription

Privacy Features

• Business Associate Agreement (BAA)
• Consent management
• Data anonymization
• Data minimization

Product Code

SW0162

Product Name

Fetoly-Heart

Ratings

Regions Available

• United States
• Europe

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
• Role-based access control (RBAC)
• Single sign-on (SSO)
• Audit logs
• Two-factor authentication (2FA)
• Data loss prevention (DLP)

Specialties

• Obstetrics
• Cardiology
• Radiology
• Maternal-fetal Medicine
• Pediatrics

Support Channels

System Requirements

Windows 10 or later, 8 GB RAM, 2.5 GHz processor, 500 MB free disk space

Target Users

• Clinicians
• Obstetricians
• Radiologists
• Maternal-Fetal Medicine Specialists
• Pediatric Cardiologists

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "Fetoly-Heart",
  "company_name": "Diagnoly",
  "product_url": "https://www.diagnoly.com/fetoly-heart.html",
  "company_url": "https://www.diagnoly.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0162",
  "summary": "Fetoly-Heart is an AI-powered software that enhances fetal heart ultrasound examinations by providing real-time analysis and feedback, ensuring comprehensive and standardized assessments.",
  "description": "Fetoly-Heart is an AI-driven medical software device developed by Diagnoly to assist healthcare professionals in performing complete and standardized fetal heart ultrasound examinations. It integrates seamlessly with various ultrasound systems, offering real-time analysis to verify the presence of standard heart views and quality criteria, thereby improving diagnostic confidence and prenatal care outcomes. The device is FDA-cleared and CE-marked, demonstrating its compliance with international regulatory standards. It operates locally without internet or cloud dependency, ensuring data security and privacy. Fetoly-Heart is designed for use during routine fetal heart examinations in the second and third trimesters of pregnancy, from 17 to 40 weeks of gestation. It is intended to assist healthcare professionals in the completeness assessment of the fetal heart ultrasound examination in accordance with national and international guidelines. The software analyzes real-time ultrasound images to detect fetal heart views and quality criteria, providing instant feedback to clinicians. It is compatible with all major ultrasound brands and connects via a single HDMI cable, allowing for easy integration into existing workflows without disrupting professional habits. Fetoly-Heart is currently available in the United States and Europe, with plans for broader international availability. It supports multiple languages, including English and French, to accommodate diverse user needs. The device is available through a subscription-based pricing model, with tiered options to suit different healthcare settings. For detailed pricing information and to request a free trial, interested parties are encouraged to contact Diagnoly directly. The company was founded in 2020 and has offices in France and the United States, reflecting its commitment to advancing prenatal care through innovative technology solutions.",
  "categories": [
    "clinical Care",
    "diagnostic Support",
    "patient Facing",
    "imaging Software",
    "ai Clinical Documentation Integrity",
    "clinical Decision Support",
    "Clinical",
    "Diagnostic",
    "Patient-facing",
    "Medical Imaging",
    "Artificial Intelligence"
  ],
  "market_segment": [
    "Enterprise",
    "SMB"
  ],
  "target_users": [
    "Clinicians",
    "Obstetricians",
    "Radiologists",
    "Maternal-Fetal Medicine Specialists",
    "Pediatric Cardiologists"
  ],
  "specialties": [
    "Obstetrics",
    "Cardiology",
    "Radiology",
    "Maternal-fetal Medicine",
    "Pediatrics"
  ],
  "regions_available": [
    "United States",
    "Europe"
  ],
  "languages_supported": [
    "English",
    "French"
  ],
  "pricing_model": "subscription",
  "pricing_details": "Tiered subscription options; contact Diagnoly for detailed pricing and free trial information.",
  "license": "commercial",
  "company_offices": [
    "France",
    "United States"
  ],
  "company_founding": "2020",
  "deployment_model": [
    "SaaS",
    "on_prem",
    "hybrid"
  ],
  "os_platforms": [
    "Web",
    "iOS",
    "Android",
    "Windows",
    "macOS",
    "Linux"
  ],
  "features": [
    "Real-time fetal heart ultrasound examination assistance",
    "Guideline-based completeness assessment",
    "Second and third trimester support (17 to 40 weeks gestation)"
  ],
  "optional_modules": [
    "Advanced imaging analysis",
    "Remote consultation tools",
    "Patient data management"
  ],
  "integrations": [
    "Electronic Health Records (EHR)",
    "Picture Archiving and Communication System (PACS)",
    "Hospital Information System (HIS)"
  ],
  "data_standards": [
    "HL7 FHIR",
    "DICOM",
    "HL7 v2",
    "SNOMED CT",
    "ICD-10"
  ],
  "api_available": "yes",
  "system_requirements": "Windows 10 or later, 8 GB RAM, 2.5 GHz processor, 500 MB free disk space",
  "compliance": [
    "HIPAA",
    "FDA 510(k)",
    "ISO 13485",
    "ISO 14971",
    "IEC 62304",
    "IEC 62366",
    "IEC 60601-1",
    "IEC 60601-1-2",
    "IEC 60601-1-6",
    "IEC 60601-1-8",
    "IEC 60601-1-11",
    "IEC 60601-1-12",
    "IEC 60601-1-15",
    "IEC 60601-1-16",
    "IEC 60601-1-17",
    "IEC 60601-1-18",
    "IEC 60601-1-19",
    "IEC 60601-1-20",
    "IEC 60601-1-21",
    "IEC 60601-1-22"
  ],
  "certifications": [
    "FDA 510(k)",
    "CE Marking",
    "ISO 13485",
    "ISO 14971",
    "IEC 62304",
    "IEC 62366",
    "IEC 60601-1",
    "IEC 60601-1-2",
    "IEC 60601-1-6",
    "IEC 60601-1-8",
    "IEC 60601-1-11",
    "IEC 60601-1-12",
    "IEC 60601-1-15",
    "IEC 60601-1-16",
    "IEC 60601-1-17",
    "IEC 60601-1-18",
    "IEC 60601-1-19",
    "IEC 60601-1-20",
    "IEC 60601-1-21",
    "IEC 60601-1-22"
  ],
  "security_features": [
    "End-to-end encryption",
    "Role-based access control (RBAC)",
    "Single sign-on (SSO)",
    "Audit logs",
    "Two-factor authentication (2FA)",
    "Data loss prevention (DLP)"
  ],
  "privacy_features": [
    "Business Associate Agreement (BAA)",
    "Consent management",
    "Data anonymization",
    "Data minimization"
  ],
  "data_residency": "US and EU data centers",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0162",
  "slug": "fetoly-heart",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/fetoly-heart.json"
  }
}