TechCrunch Disrupt Battlefield 2023 winner, Biotics AI, announced on Monday that it has received FDA clearance for its AI software that helps detect fetal abnormalities in ultrasound images.

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Biotics AI received FDA clearance for its computer vision AI software that detects fetal abnormalities in ultrasound images. The technology supports quality assessment, anatomical completeness, automated reporting, and clinical workflow integration. Trained on 11,000 diverse ultrasounds, the system aims to address poor prenatal outcomes in the U.S., particularly for high-risk demographics. The three-year FDA approval process required tight alignment between engineering, product, clinical, and regulatory teams. The company now plans to scale across health systems and expand features for fetal medicine and reproductive health.

Biotics AI, Battlefield 2023, gains FDA approval for its AI-powered fetal ultrasound product