# Sonio

> AI ultrasound reporting software for OB-GYN and maternal-fetal medicine teams, with FDA 510(k) cleared and CE marked clinical AI. A Samsung Medison company.

Sonio is a cloud-based platform that brings artificial intelligence to prenatal ultrasound exams. Founded in April 2020 in Paris by experts in maternal-fetal medicine and data science, Sonio was acquired by Samsung Medison in September 2024. The company's mission is to give access to high-quality prenatal care everywhere by uniting technology and clinical expertise.

Sonio serves the United States, France and the European Union from offices in New York, Boston, Cambridge and Paris.

## About Sonio

- [About Sonio](https://sonio.ai/about-us/): Mission and origin story. Sonio is on a mission to improve women's and children's health by promoting access and quality of care through technological innovation, medical expertise and collective intelligence.
- [Our team](https://sonio.ai/team/): 59 people across 16 nationalities. The team unites maternal-fetal medicine specialists, data scientists and product experts to build AI for prenatal care.
- [Scientific Advisory Board](https://sonio.ai/scientific-advisory-board/): Fetal medicine and applied mathematics experts from Necker University Hospital, Ecole Polytechnique, Harvard Medical School, University of Birmingham and Massachusetts General Hospital. The SAB shapes Sonio's clinical roadmap and ensures the highest standards of medical accuracy, safety and efficacy.
- [Partners](https://sonio.ai/partners/): Medical, distribution and technology partners worldwide, including hospitals (Necker), distribution partners across Asia, Africa, Europe and Latin America, technical partners (Ecole Polytechnique, Prairie, Deeptech Founders), and ultrasound manufacturer Samsung Medison.
- [Contact](https://sonio.ai/contact/): Reach the Sonio team to learn more about the platform.

## Products

- [Sonio platform](https://sonio.ai/platform/): The full AI-powered ultrasound reporting solution for OB-GYN and MFM teams. Combines visual checklists, image management, automated reporting, image and video sharing, and AI-driven practice analytics.
- [Sonio Detect](https://sonio.ai/products/#sonio-detect): FDA 510(k) cleared (K230365) and CE class IIa medical device (Notified Body BSI, CE2797). Real-time AI software that analyzes fetal ultrasound images and clips to automatically detect views, identify anatomical structures and verify quality criteria. Trained on over 1,000,000 real-life ultrasound images.
- [Sonio Pro](https://sonio.ai/products/#sonio-pro): US class I medical device (medical image communication device). SaaS platform for OB-GYN ultrasound exams that uploads DICOM media, acts as a modality worklist and integrates with EMR, billing and PACS systems via HL7 protocols. Not classified as a medical device under EU regulations.
- [Sonio Share](https://sonio.ai/sonio-share/): Secure paperless solution to share ultrasound images, video clips and reports with patients via QR codes or secure email links. Compliant with HIPAA, SOC2 and EU-GDPR. Media retained up to 10 years on certified cloud infrastructure.
- [AI capabilities](https://sonio.ai/artificial-intelligence/): The Sonio AI is built by clinicians for clinicians, with data scientists from Ecole Polytechnique. Trained on 1,000,000 scan images, 30,000 clips, 35,000 prenatal exams and 150,000 annotations. Reliable across patient demographics including high BMI, maternal age and ethnicity.
- [Integration](https://sonio.ai/integration/): Vendor-neutral interoperability with EMR (HL7, FHIR, Mirth), billing (HL7 DFT, CPT and ICD-10 codes), DICOM ultrasound systems, VNA/PACS for archiving, and IMO for medical terminology.

## For specific roles and organizations

- [For sonographers](https://sonio.ai/sonographer/): Real-time feedback from readers and AI, standardized image order, secure patient image sharing through QR codes, step-by-step exam guidance.
- [For OB-GYN and MFM readers](https://sonio.ai/ob-gyn-maternal-fetal-medicine/): AI-powered reporting, image management, auto-fill CPT codes, seamless EMR and PACS integration.
- [For clinical executives](https://sonio.ai/clinical-executive/): Standardize prenatal practices across sites, evaluate performance through analytics, upskill teams and facilitate cross-team collaboration.
- [For healthcare IT teams](https://sonio.ai/it-overview/): Flexible deployments (Sonio cloud, private cloud, on-premise), HIPAA and SOC2 compliance, HL7 and DICOM integrations, fine-grained access control.
- [For Women's Health MSOs](https://sonio.ai/women-health-mso/): Centralize IT infrastructure management across affiliate practices with practice analytics across sites.
- [For Academic Medical Centers](https://sonio.ai/academic-medical-center/): Ensure consistent prenatal ultrasound quality across staff and trainees, with training support for residents and fellows.
- [For Community Medical Centers](https://sonio.ai/community-medical-center/): Extend access to high-quality prenatal care beyond centers of excellence with standardized protocols and specialist-level feedback.
- [For Private OB-GYN Practices](https://sonio.ai/private-practice/): Standardized protocols and operational efficiency for independent obstetrics clinics.
- [Maternal-Fetal Medicine](https://sonio.ai/mfm-ultrasound-reporting-software/): AI ultrasound reporting software specifically built for MFM teams. Cut manual data entry and align reporting to MFM protocols.

## Security and regulatory

- [Security and Regulatory](https://sonio.ai/security-regulatory/): Sonio complies with HIPAA, EU-GDPR, HDS, ISO 13485 and SOC2 Type 2 standards. Cybersecurity measures include data encryption at rest and in transit, web application firewall, intrusion detection, zero-trust security mechanisms and isolated multi-region deployments.
- [Cybersecurity datasheet](https://sonio.ai/cybersecurity-datasheet/): Detailed overview of Sonio's security policies, software development processes and compliance with security standards.
- [Product data sheet](https://sonio.ai/product-data-sheet/): Comprehensive overview of the Sonio platform: clinical AI capabilities, key features, integrations and security compliance.

## Clinical evidence and content

- [Clinical Evidence library](https://sonio.ai/clinical-evidence/): Studies, white papers, clinical cases and videos on AI-powered prenatal ultrasound. The library includes peer-reviewed posters, internal studies and case studies.
- [Customer testimonials](https://sonio.ai/customer-testimonials/): Real user stories from sonographers and OB-GYN practitioners using Sonio in their daily practice.
- [Blog](https://sonio.ai/blog-us/): Articles on AI ultrasound, prenatal care, maternal-fetal medicine, practice management insights and clinical case studies.
- [News and announcements](https://sonio.ai/news/): Company updates, events, partnerships and funding announcements, including FDA clearances and the Samsung Medison acquisition.

## Key facts and figures

- Founded: April 2020 in Paris, France
- Acquisition: Acquired by Samsung Medison in September 2024
- Team: 59 people across 16 nationalities, with 50% women and 65% women on the board
- AI training data: Over 1,000,000 ultrasound images, 30,000 clips, 35,000 prenatal exams and 150,000 annotations
- Regulatory status (Sonio Detect): FDA 510(k) cleared (K230365), CE class IIa under EU Regulation 2017/745 (Notified Body BSI, CE2797)
- Compliance: HIPAA, EU-GDPR, HDS, ISO 13485, SOC2 Type 2
- Offices: Paris (HQ), New York, Boston, Cambridge
- Markets served: United States, France, European Union

## Legal

- [Privacy policy](https://sonio.ai/privacy-policy/): How Sonio collects, uses and protects personal data in compliance with GDPR.
- Legal entity: Sonio SAS, RCS Paris 883 053 571
- Headquarters: 147 Rue d'Aboukir, 75002 Paris, France