Sonio Detect

JSON twin: https://www.healthaidb.com/software/sonio-detect.json

Company Name

Sonio

Product URL

https://sonio.ai/products/

Company URL

https://sonio.ai

Categories

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

Summary

Sonio Detect is an AI-powered software that assists ultrasound practitioners in real-time during fetal ultrasound examinations, enhancing quality and efficiency.

Description

Sonio Detect is an FDA 510(k) cleared AI software designed to support ultrasound practitioners by automatically detecting views, anatomical structures, and verifying quality criteria in real-time during fetal ultrasound exams. It integrates with various ultrasound machines and adapts to diverse patient demographics, including variations in BMI, maternal age, and ethnicity. The software has demonstrated high sensitivity and specificity across different patient subgroups. Additionally, Sonio Detect has been FDA cleared for analysis of prenatal ultrasound exams in August 2023. ([auntminnie.com](https://www.auntminnie.com/clinical-news/ultrasound/article/15633974/fda-clears-sonios-ai-for-prenatal-ultrasound-software?utm_source=openai))

Api Available

yes

Certifications

• FDA 510(k)
• CE/MDR
• ONC
• ISO 13485

Company Founding

2020

Company Offices

• United States
• France

Compliance

• HIPAA
• GDPR
• HITECH
• SOC 2
• ISO 27001

Customers

Data Residency

EU-only, US/EU regions, BYO cloud region

Data Standards

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

Deployment Model

• SaaS
• on_prem
• hybrid

Features

• Automatic detection and labeling of fetal ultrasound views
• Identification of anatomical structures within ultrasound views
• Verification of ultrasound image quality against standardized criteria
• Real-time feedback on image quality during ultrasound exams
• Automated sorting and management of ultrasound images and videos
• Integration with existing ultrasound machines and clinical systems
• Voice-controlled reporting assistant for hands-free documentation
• Customizable reporting templates based on ultrasound findings
• Clinical decision support features powered by AI algorithms
• Automated population of report fields using AI and voice input
• Visual checklist to track required ultrasound views during exams
• Patient app for secure sharing of ultrasound images and reports
• Practice analytics to monitor and improve clinical performance
• Cloud-based technology for secure, remote access to ultrasound exams
• Continuous software updates to incorporate latest imaging technology and AI advancements
• Compliance with HIPAA privacy and security requirements
• ISO 13485 certified quality management system
• SOC 2 Type 2 compliance for data security
• EU-GDPR compliance for data protection
• Flexible deployment options including isolated multi-region deployments

Id

SW0224

Integration Partners

Integrations

• Ultrasound machines
• EHR systems
• PACS/VNA
• Billing systems
• eFAX support
• IMO
• LOINC
• DICOM worklist
• HL7 (ADT, SIU, ORU, ORM, etc.)
• FHIR
• Custom integrations

Languages Supported

• English
• French

Last Updated

2025-10-11

License

Commercial

Market Segment

• Enterprise
• SMB

Optional Modules

• Sonio Voice
• Sonio Suspect

Os Platforms

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

Pricing Details

Contact vendor for pricing information.

Pricing Model

Subscription

Privacy Features

• BAA available
• consent mgmt
• anonymization
• data minimization

Product Code

SW0224

Product Name

Sonio Detect

Ratings

Regions Available

• United States
• France

Related Urls

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

Release Year

Security Features

• Encryption
• RBAC
• SSO/SAML
• audit logs
• 2FA
• DLP

Specialties

• Obstetrics
• Gynecology
• Maternal-fetal Medicine

Support Channels

System Requirements

Major OS/DB/hardware needs, or empty if SaaS-only

Target Users

• Sonographers
• OB/GYNs
• Maternal-Fetal Medicine Specialists
• Fetal Surgeons

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "Sonio Detect",
  "company_name": "Sonio",
  "product_url": "https://sonio.ai/products/",
  "company_url": "https://sonio.ai",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0224",
  "summary": "Sonio Detect is an AI-powered software that assists ultrasound practitioners in real-time during fetal ultrasound examinations, enhancing quality and efficiency.",
  "description": "Sonio Detect is an FDA 510(k) cleared AI software designed to support ultrasound practitioners by automatically detecting views, anatomical structures, and verifying quality criteria in real-time during fetal ultrasound exams. It integrates with various ultrasound machines and adapts to diverse patient demographics, including variations in BMI, maternal age, and ethnicity. The software has demonstrated high sensitivity and specificity across different patient subgroups. Additionally, Sonio Detect has been FDA cleared for analysis of prenatal ultrasound exams in August 2023. ([auntminnie.com](https://www.auntminnie.com/clinical-news/ultrasound/article/15633974/fda-clears-sonios-ai-for-prenatal-ultrasound-software?utm_source=openai))",
  "categories": [
    "clinical Care",
    "diagnostic Support",
    "patient Facing",
    "Clinical",
    "Diagnostic",
    "Patient-facing"
  ],
  "market_segment": [
    "Enterprise",
    "SMB"
  ],
  "target_users": [
    "Sonographers",
    "OB/GYNs",
    "Maternal-Fetal Medicine Specialists",
    "Fetal Surgeons"
  ],
  "specialties": [
    "Obstetrics",
    "Gynecology",
    "Maternal-fetal Medicine"
  ],
  "regions_available": [
    "United States",
    "France"
  ],
  "languages_supported": [
    "English",
    "French"
  ],
  "pricing_model": "Subscription",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "Commercial",
  "company_offices": [
    "United States",
    "France"
  ],
  "company_founding": "2020",
  "deployment_model": [
    "SaaS",
    "on_prem",
    "hybrid"
  ],
  "os_platforms": [
    "Web",
    "iOS",
    "Android",
    "Windows",
    "macOS",
    "Linux"
  ],
  "features": [
    "Automatic detection and labeling of fetal ultrasound views",
    "Identification of anatomical structures within ultrasound views",
    "Verification of ultrasound image quality against standardized criteria",
    "Real-time feedback on image quality during ultrasound exams",
    "Automated sorting and management of ultrasound images and videos",
    "Integration with existing ultrasound machines and clinical systems",
    "Voice-controlled reporting assistant for hands-free documentation",
    "Customizable reporting templates based on ultrasound findings",
    "Clinical decision support features powered by AI algorithms",
    "Automated population of report fields using AI and voice input",
    "Visual checklist to track required ultrasound views during exams",
    "Patient app for secure sharing of ultrasound images and reports",
    "Practice analytics to monitor and improve clinical performance",
    "Cloud-based technology for secure, remote access to ultrasound exams",
    "Continuous software updates to incorporate latest imaging technology and AI advancements",
    "Compliance with HIPAA privacy and security requirements",
    "ISO 13485 certified quality management system",
    "SOC 2 Type 2 compliance for data security",
    "EU-GDPR compliance for data protection",
    "Flexible deployment options including isolated multi-region deployments"
  ],
  "optional_modules": [
    "Sonio Voice",
    "Sonio Suspect"
  ],
  "integrations": [
    "Ultrasound machines",
    "EHR systems",
    "PACS/VNA",
    "Billing systems",
    "eFAX support",
    "IMO",
    "LOINC",
    "DICOM worklist",
    "HL7 (ADT, SIU, ORU, ORM, etc.)",
    "FHIR",
    "Custom integrations"
  ],
  "data_standards": [
    "FHIR",
    "HL7 v2",
    "DICOM",
    "SNOMED",
    "ICD-10"
  ],
  "api_available": "yes",
  "system_requirements": "Major OS/DB/hardware needs, or empty if SaaS-only",
  "compliance": [
    "HIPAA",
    "GDPR",
    "HITECH",
    "SOC 2",
    "ISO 27001"
  ],
  "certifications": [
    "FDA 510(k)",
    "CE/MDR",
    "ONC",
    "ISO 13485"
  ],
  "security_features": [
    "Encryption",
    "RBAC",
    "SSO/SAML",
    "audit logs",
    "2FA",
    "DLP"
  ],
  "privacy_features": [
    "BAA available",
    "consent mgmt",
    "anonymization",
    "data minimization"
  ],
  "data_residency": "EU-only, US/EU regions, BYO cloud region",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0224",
  "slug": "sonio-detect",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/sonio-detect.json"
  }
}