FDA clears AI software for fetal ultrasound
AI software now approved could transform how fetal abnormalities are detected.
BioticsAI has received FDA approval for its AI software that detects fetal abnormalities in ultrasound images. The technology aims to improve diagnostic accuracy and clinical workflows.
Founded by CEO Robhy Bustami, the company applies computer vision to enhance ultrasound quality and automated reporting. Development focused on consistent performance across diverse patient populations.
The software helps assess image quality and anatomical completeness, and generates automated reports. Bustami emphasised the importance of reliable performance for high-risk demographics.
With regulatory approval, BioticsAI plans nationwide adoption across health systems. Additional features for fetal medicine and reproductive health are also under development.
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