Sonio Detect is a software tool that uses machine learning to help healthcare professionals during fetal ultrasound exams by automatically detecting views, anatomical structures, and verifying the quality of images in real-time. This supports sonographers and fetal specialists to ensure comprehensive and high-quality ultrasound examinations for fetuses from 11 to 37 weeks gestational age.
Intended Use
Sonio Detect is intended to analyze fetal ultrasound images and clips using machine learning techniques to automatically detect views, detect anatomical structures within the views and verify quality criteria of the views. The device is intended for use as a concurrent reading aid during the acquisition and interpretation of fetal ultrasound images.
Technology
Sonio Detect is a Software as a Service (SaaS) that receives fetal ultrasound images and clips submitted via edge software from ultrasound machines, performs automatic detection of views, anatomical structures within views, and verifies quality criteria based on standardized checks. It runs in real-time and allows user interaction to override results.
Performance
Performance testing included software verification, validation, and standalone bench testing on 17885 fetal ultrasound images from multiple clinical sites. The device demonstrated high sensitivity and specificity for detecting fetal ultrasound views, anatomical structures, and verifying quality criteria across various fetal brain and heart views. Testing also covered different ultrasound machine manufacturers and patient subgroups.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/10/2023
5 months - 2
FDA Approval
7/25/2023
Other devices from Sonio
- Sonio Detect2024 • 510K
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