Sonio is a cloud-native AI platform that standardizes fetal ultrasound workflows, from acquisition and quality control to reporting and billing. Its Sonio Detect module is FDA 510(k)-cleared and CE-marked, providing real-time view and anatomy detection for sonographers and OB-GYN/MFM readers. Founded in Paris in 2020 and acquired by Samsung Medison in 2024, Sonio integrates deeply with PACS, EHR, and billing systems and holds a strong compliance stack including HIPAA, SOC 2 Type 2, and ISO 13485.
Key features
- Sonio Detect: FDA 510(k)-cleared, CE-marked AI that detects fetal ultrasound views, anatomical structures, and quality criteria in real time
- Sonio Pro: Class I medical image communication device ensuring proper screening exam performance
- Automated reporting with auto-populated fields from ultrasound findings
- Visual checklist and automated image management/sorting
- Practice analytics for performance insights and sonographer training
- Report sharing via fax to referring providers and secure patient app sharing
Strengths
- FDA 510(k) clearance and CE marking for clinical AI — a high regulatory bar in imaging AI
- Deep integrations across PACS, EHR (HL7/FHIR), DICOM worklist, and billing (CPT/ICD-10)
- Backed by Samsung Medison since its September 2024 acquisition
- Strong compliance stack: SOC 2 Type 2, HIPAA/HITECH, ISO 13485, HDS, EU-GDPR
- Isolated multi-region deployments keep data within a chosen region (EU, US, etc.)
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