Biotics AI, the winner of TechCrunch Disrupt Battlefield 2023, announced on Monday that it has received FDA clearance for its AI software designed to detect fetal abnormalities in ultrasound images.
The product was envisioned by founder and 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 United States. 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.
The technology uses computer vision AI to support fetal ultrasound quality assessment, anatomical completeness, automated reporting, and seamless integration into clinical workflows. Bustami hopes his technology will help the United States combat its status of having one of the worst prenatal outcomes for mothers among high-income nations. Black women in particular face a very high rate of maternal deaths. Bustami said that the prenatal ultrasound has become the cornerstone of monitoring pregnancies, but its low-quality images can lead to misdiagnosis.
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 technology 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.
The CEO said it took just under three years to go through the FDA process, including testing and validating the product. The experience taught him and his team how critical it is for engineering, product, clinical, and regulatory work to be tightly aligned from the very beginning. By designing the product, clinical validation, and regulatory pathway together, rather than sequentially, they were able to move quickly.
Now with FDA clearance, Bustami said the company’s next focus is scaling across various health systems nationwide. He also has plans to add more features for fetal medicine and reproductive health. The company is positioned to scale both distribution and clinical impact while continuing to deepen the power of its technology.