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Intended Use

Sonio Suspect is intended to assist interpreting physicians, during or after fetal ultrasound examinations, by automatically identifying and characterizing abnormal fetal ultrasound findings on detected views, using machine learning techniques. It is used as a concurrent reading aid on acquired images, during and/or after fetal ultrasound examinations, and provides information that may be useful in rendering potential diagnosis.

Technology

Sonio Suspect is a cloud-based Software as a Service (SaaS) solution that processes fetal ultrasound images using computer vision and machine learning algorithms. It automatically detects ultrasound views, evaluates specific abnormal fetal findings, and presents results during or after the ultrasound exam. It supports connection via API to ultrasound machines and allows manual overrides by the user.

Performance

Sonio Suspect underwent extensive software verification, standalone performance testing on 8745 fetal ultrasound images demonstrating a sensitivity of 93.2% and specificity of 90.8%, and a clinical multi-reader study showing improved reader accuracy with AI assistance (AUC improved from 68.9% unassisted to 90.0% assisted). The device performed validation across multiple subgroups and ultrasound manufacturers.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    11/22/2024

    3 months
  • 2

    FDA Approval

    2/21/2025

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