Sonio Detect

by Sonio  · Based in France → — Securing pregnancy care
Maternal-Fetal Medicine Obstetrics & Gynecology
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Regulatory Status Disclosed

Overview

Sonio Detect is an FDA 510(k) cleared artificial intelligence (AI) software designed to assist healthcare professionals during fetal ultrasound examinations. It is intended for use by sonographers, OB/GYNs, and maternal-fetal medicine (MFM) specialists in various care settings, including private practices, women’s health organizations, and academic medical centers.

The tool integrates into clinical workflows by receiving fetal ultrasound images and clips from ultrasound machines in real-time. Sonio Detect automatically identifies views and anatomical structures within supported views and verifies image quality against standardized criteria. This includes checking for the presence or absence of anatomical structures and assessing zoom levels for specific views. The software provides real-time feedback on image quality during exams and helps ensure exam completeness.

Notable capabilities include the automatic detection of 14 Trimester 1 views and 40 Trimester 2/3 views, as well as 58 anatomical structures across various regions. It also offers automatic localization of specific structures and continues to detect placenta location and fetal sex. Sonio Detect aims to standardize fetal ultrasound quality through AIUM or site-specific templates and automated reporting. The platform is cloud-native, compatible with various ultrasound machine manufacturers, and integrates with existing systems such as EHRs, PACS, and billing systems. Users can review and edit/override the AI’s outputs.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered ultrasound reporting
  • Real-time detection of views and anatomical structures
  • Automated quality criteria verification
  • AI-powered visual checklist for exam completeness
  • Streamlined image management and organization
  • Automated report generation with auto-filled fields
  • Secure image and video sharing with patients and referring providers
  • AI-driven practice analytics and performance monitoring
  • Customizable report templates and study protocols
  • Seamless integrations with EHR, PACS, and billing systems

Use Cases

  • Enhancing prenatal care efficiency and quality
  • Assisting sonographers in real-time fetal ultrasound examinations
  • Improving diagnosis and detection of fetal anomalies
  • Streamlining workflow for OB-GYNs and Maternal-Fetal Medicine specialists
  • Implementing quality control for medical imaging in prenatal care
  • Optimizing practice management and analytics for Women's Health departments

What Physicians Need to Know

Fetal Monitoring AI
Sonio Detect is an FDA 510(k) cleared AI product that empowers ultrasound practitioners to perform routine fetal ultrasound examinations in real-time. It automatically detects views and anatomical structures within supported views, and verifies quality criteria of these views. The system improves fetal anomaly detection by 22 points, enabling earlier diagnosis as early as 11 weeks of gestation. It reliably recognizes fetal ultrasound views (T1, T2/T3) and structures like the brain and heart with high sensitivity and specificity. The latest version also automatically detects placenta location, fetus sex, and structures such as the placenta and crown-rump length/Nuchal translucency.
Ultrasound Image Analysis
Sonio Detect utilizes machine learning to analyze fetal ultrasound images and clips, providing real-time feedback on image quality and exam completeness. It automatically detects views and anatomical structures, and verifies quality criteria against standardized guidelines. The AI can automatically extract views from cine-loops, reducing complexity and exam time for sonographers. It also aids in identifying abnormal findings across various ultrasound views of the heart, brain, and abdomen.
Pregnancy Risk Assessment
The Sonio platform, which includes Sonio Detect, analyzes data from various sources, including medical history and risk factors, to support ultrasound physicians in prenatal screening. By improving the early detection of fetal anomalies, it enables timely interventions and contributes to improved maternal and fetal outcomes. The system's dynamic protocols help practitioners avoid overlooking implications of patient risk factors.
Prenatal Testing Integration
Sonio Pro, part of the Sonio solution, interacts with healthcare professionals' IT systems via HL7 protocol, facilitating interoperability with Electronic Medical Records (EMR) and billing systems. Sonio integrates bidirectionally with EMRs using connectors like Mirth or directly via HL7/FHIR, allowing access to comprehensive patient records, including demographic information, medical history, prior diagnoses, and past ultrasound results.
Physician Tip

Physicians can leverage Sonio Detect for real-time quality control during fetal ultrasound examinations, ensuring adherence to standardized criteria and completeness of exams. The AI's capability for early detection of fetal anomalies is crucial for timely interventions and improved patient outcomes. Utilizing the AI-powered visual checklist and automated reporting features can streamline workflows, reduce manual tasks, and enhance reporting accuracy and consistency. Furthermore, Sonio can assist in standardizing clinical guidelines across teams and serve as a valuable tool for training and upskilling staff.

Sonio offers robust interoperability, integrating seamlessly into existing clinical workflows. Sonio Pro is compatible with all ultrasound machine manufacturers and can send and upload media in DICOM format. It acts as a Worklist for ultrasound equipment and integrates bidirectionally with EMRs via HL7/FHIR. Integration with billing systems is supported through HL7 DFT messages, including CPT and ICD-10 coding. Sonio also integrates with PACS/VNA for archiving studies and supports clinical standards like IMO and LOINC.

Details

Category OB/GYN AI, Radiology & Imaging AI
Pricing Contact for pricing — Sonio Start; Sonio Plus; Sonio Premium; Sonio Enterprise
DeploymentCloud-based; flexible for on-premise or virtual private cloud
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

Sonio Detect is an FDA 510(k) cleared product (K240406). It is intended to analyze fetal ultrasound images and clips using machine learning techniques to automatically detect views, anatomical structures within the views, and verify quality criteria. An updated version received clearance in May 2024.
Integrations
EHR Not specified
Specialties Maternal-Fetal Medicine, Obstetrics & Gynecology

What the Web Says

Sonio Detect is an AI-powered solution designed to enhance prenatal ultrasound examinations by automating various aspects of the workflow, improving diagnostic accuracy, and ensuring quality control. It has received FDA clearance for multiple versions of its product and a CE mark in France, indicating its expansion into Europe. The system aims to streamline reporting, verify exam completeness, provide real-time feedback to sonographers, and integrate with existing healthcare systems. While there's strong positive sentiment from articles and testimonials, one adverse event report raises concerns about the AI algorithm's accuracy in labeling fetal structures.

Overall: Mixed

Strengths

  • Enhances diagnostic accuracy and improves patient outcomes
  • Streamlines workflow and reduces time spent on manual tasks
  • AI automatically populates fields for quick and error-free reporting
  • Built-in quality control verifies exam completeness and accuracy of views
  • Provides real-time feedback to sonographers on image quality
  • Seamless integration with existing systems like PACS, FAX, and EHR

Limitations

  • One adverse event report mentions faulty AI algorithm wrongly labeling fetal structures
  • Potential for the system to display structures as visualized even when not present, leading to false normalcy

Based on reviews from: Medium, ProQuest, Sonio (Customer Testimonials), MAUDE Adverse Event Report (FDA), Diagnostic Imaging, Sonio (Clinical Evidence), YouTube, Sonio (Product Page)

Last updated: 2026-07-19

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Press & Coverage

Sonio.ai
Sonio Announces FDA Clearance of the 3rd version of Sonio Detect
Sonio announced FDA 510(k) clearance for the third version of Sonio Detect, an AI-powered solution designed to ensure high-quality ultrasound exams by automatically detecting views, anatomical structures, and verifying quality criteria. This version expands the scope of detected structures and views, covering up to 65% of ISUOG/AIUM guidelines.
2026-03
Sonio.ai
Sonio receives FDA clearance for Sonio Suspect Integration Configuration
Sonio received FDA clearance for Sonio Suspect Integration Configuration, a new configuration of Sonio Suspect that can be integrated into ultrasound machines. This marks Sonio's fifth FDA clearance in under three years, demonstrating continued progress in AI capabilities for ultrasound.
2026-06
Sonio.ai
Sonio Announces FDA Clearance of Sonio Suspect
Sonio announced FDA 510(k) clearance for Sonio Suspect, an AI module designed to enhance prenatal screening with AI-driven anomaly detection and real-time quality control. It aims to support early and accurate diagnosis by identifying anomalies across key fetal regions.
2025-02
Contemporary OB/GYN
FDA clears Sonio Suspect AI for fetal anomaly detection
Sonio's AI-powered Sonio Suspect model received FDA clearance for detecting fetal anomalies, improving detection by 22 points and enabling earlier diagnosis. This addresses a critical gap where up to 51% of anomalies are missed during standard screenings.
2025-02
Diagnostic Imaging
FDA Clears Updated Version of Sonio Detect Fetal Ultrasound Device
The FDA granted 510(k) clearance for the second version of the Sonio Detect fetal ultrasound device, which boasts 91.4% sensitivity for T1 fetal ultrasound views and 93.7% sensitivity for T2 and T3 views. It also enables 63% of AIUM exam protocols without manual annotation.
2024-05
Samsung Global Newsroom
Samsung Announces Acquisition of Sonio To Strengthen Its Leading Position in Cutting-Edge Medical Devices
Samsung Medison announced its acquisition of Sonio SAS, a fetal ultrasound AI software company, to accelerate global growth in maternal care and ultrasound technology. Sonio Detect, an FDA 510(k) cleared AI assistant, will continue to be compatible with all ultrasound device makers.
2024-05
AuntMinnieEurope
Regulators approve Sonio's AI tool for prenatal ultrasound
Sonio received FDA regulatory approval for its Sonio Detect software for use in prenatal ultrasound examinations. The AI tool can detect views, anatomical structures, and verify quality criteria in real-time, with a 92% sensitivity in a validation study of 17,000 images.
2023-08
Sonio.ai
Sonio Detect received FDA 510(k) clearance
Sonio announced that its AI-powered solution, Sonio Detect, received FDA 510(k) clearance. This SaaS solution assists sonographers, OB/GYNs, and MFMs in performing routine fetal ultrasound examinations in real-time by automatically detecting and labeling views, anatomical structures, and verifying quality criteria.
2023-08

Videos

Product demos, reviews, and walkthroughs for Sonio Detect.

View all on YouTube

Frequently Asked Questions

Sonio Detect is a manufacturer-agnostic, AI-powered software that integrates into existing ultrasound workflows as a concurrent reading aid. It automatically detects views, anatomical structures, and verifies quality criteria of fetal ultrasound images and clips in real-time, aiming to enhance the quality of fetal exams and streamline reporting.
Sonio Detect is FDA 510(k) cleared in the US and holds a Class IIa CE Mark under EU Regulation 2017/745. The platform complies with stringent security and data protection standards, including HIPAA, EU-GDPR, HDS certification, ISO 13485, and SOC2 Type 2 compliance, ensuring data encryption and isolated multi-region deployments.
While Sonio Detect aims to improve exam quality and efficiency, it is intended as a reading aid and not a standalone diagnostic tool. Earlier research on a similar system, SONIO, noted potential for false-positive diagnoses in the absence of congenital disease, which would need to be addressed in further studies.
Yes, there are several alternatives in the market for ultrasound reporting and AI-assisted imaging, though direct AI-powered fetal anomaly detection competitors to Sonio Detect's specific capabilities might vary. General cloud-based ultrasound reporting software and handheld ultrasound devices from companies like GE (Vscan Air), Philips (Lumify), Butterfly iQ, and Exo Iris offer various features for image acquisition and management.
Specific pricing for Sonio Detect is not publicly disclosed, and interested parties are advised to contact Sonio directly for pricing information. As a Software as a Service (SaaS) solution, it likely involves subscription-based models, which can offer cost-effectiveness and scalability by only paying for needed capacity and services.
Sonio Detect has demonstrated high accuracy in clinical testing, with over 92% sensitivity in detecting labels and types of ultrasound images. It reliably recognizes fetal ultrasound views (e.g., T1 views with 91.4% sensitivity and T2/T3 views with 93.7% sensitivity) and structures like the brain (93.4% sensitivity, 94.9% specificity) and heart (91.9% sensitivity, 97.6% specificity) in the second and third trimesters.
Sonio Detect is designed for seamless integration with existing clinical systems, including Electronic Health Records (EHR) via HL7 and FHIR, Picture Archiving and Communication Systems (PACS), and various ultrasound machines. It supports vendor-neutral compatibility and clinical integration standards like DICOM worklist, ensuring efficient data exchange and streamlined workflows.

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Suggest an Edit → | Last Verified: 2026-04-19 | First Added: 2026-04-19
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