"The product was envisioned by founder CEO Robhy Bustami, who was raised in a family of obstetricians, including his mother, sister, and uncle. He spent a lot of time in hospitals growing up, often traveling with his mother as she provided maternal care throughout the U.S. After learning to code and studying computer science at UC Irvine, Bustami teamed up with Salam Khan, Chaskin Saroff, and Dr. Hisham Elgammal in 2021 to launch Biotics AI,"
"Bustami said the hardest part was not building his AI models, which were trained on a diverse set of 11,000 ultrasounds, but ensuring the tech performed reliably in the real world, especially on demographics with the highest risk for a tragic outcome. "In an environment where disparities in healthcare outcomes are well documented, it was critical to demonstrate consistent performance across patient subgroups, not just in idealized cases," Bustami continued."
Biotics AI obtained FDA clearance for AI software designed to detect fetal abnormalities and support ultrasound quality assessment, anatomical completeness, and automated reporting. The company was founded by Robhy Bustami and partners in 2021, drawing on Bustami’s upbringing in a family of obstetricians and his computer science training. The models were trained on a diverse set of 11,000 ultrasounds. Major development challenges included validating consistent real-world performance across high-risk demographic subgroups. The regulatory process lasted just under three years and reinforced the need for tight alignment between engineering, product, clinical, and regulatory teams. The aim is to improve prenatal outcomes and address racial disparities in maternal health.
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