AI-Enabled Fetal Ultrasound Software Gets FDA Clearance


With reported performance validation on over 17,000 ultrasound images, Sonio Detect employs artificial intelligence (AI) to help ensure quality criteria for fetal ultrasound imaging of the brain and heart.

The Food and Drug Administration (FDA) has granted 510(k) clearance for Sonio Detect (Sonio), a fetal ultrasound software as a service (SaaS) platform that utilizes artificial intelligence (AI) to enhance the assessment of fetal heart and brain structures.

Emphasizing Sonio Detect’s robust accuracy in identifying ultrasound views and quality criteria, Sonio said the technology demonstrated a 92 percent sensitivity in performance validation testing on over 17,000 ultrasound images.

Sonio claimed the technology with Sonio Detect increases the efficiency of fetal heart and brain assessment and may facilitate improved diagnosis of fetal anomalies.

“Bringing the first easy to use, manufacturer agnostic and efficient quality control solution to all OBGYNs, (maternal fetal medicine specialists) and sonographers, we believe better screening will lead to better detection of potential anomalies or reassurance to provide better maternal care. Our goal is to transform prenatal care by providing a reliable tool that ensures better health outcomes for both mothers and babies,” noted Cecile Brosset, the chief executive officer and co-founder of Sonio.

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