FDA clears second version of Sonio Detect

The U.S. Food and Drug Administration (FDA) has cleared AI ultrasound company Sonio's second version of its prenatal ultrasound software Sonio Detect.

The latest version of Sonio Detect has the following new capabilities:

  • Detects fetal ultrasound T1 views with 91.4% sensitivity and T2/T3 views with 93.7% sensitivity.
  • Allows for automatic extraction of views from clips to reduce complexity and exam time for sonographers.
  • Makes more than 60% of exam protocols possible without manual annotation.
  • Detects brain structures with 93.4% sensitivity and 94.9% specificity, and heart and thorax structures with 91.9% sensitivity and 97.6% specificity. Sonio also automatically detects structures of placenta and crown-rump length/Nuchal translucency and automatically detects placenta location and fetus sex, the company added.
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