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Biotics AI, the winner of TechCrunch Disrupt Battlefield 2023, has received FDA clearance for its AI software designed to detect fetal abnormalities in ultrasound images. Founded by Robhy Bustami, the technology aims to address poor prenatal outcomes in the U.S., particularly for high-risk demographics. The software uses computer vision to assess ultrasound quality, ensure anatomical completeness, and automate reporting.
Trained on 11,000 diverse ultrasounds, the team focused on real-world reliability and equal performance across patient subgroups. After a nearly three-year FDA approval process that emphasized integrated engineering and clinical work, Biotics AI plans to scale nationwide and expand into reproductive health.
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