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

Biotics AI, the winner of the TechCrunch Disrupt Battlefield 2023, proudly announced on Monday that it has received FDA clearance for its innovative AI software designed to detect fetal abnormalities in ultrasound images. The brainchild of founder and CEO Robhy Bustami, who hails from a family deeply rooted in obstetrics, this technology aims to enhance prenatal care across the United States. Growing up alongside his mother, sister, and uncle—each dedicated to maternal care—Bustami spent significant time in hospitals, which fueled his passion for healthcare. After mastering coding and earning a degree in computer science from UC Irvine, he partnered with Salam Khan, Chaskin Saroff, and Dr. Hisham Elgammal in 2021 to establish Biotics AI. This groundbreaking technology employs computer vision AI to enhance fetal ultrasound quality assessments, ensuring anatomical completeness and facilitating automated reporting. Bustami emphasized the urgency of this development, noting that the U.S. faces troubling prenatal outcomes compared to other high-income nations, particularly affecting Black women who experience higher maternal mortality rates. Bustami described prenatal ultrasound as the “cornerstone” of pregnancy monitoring, but acknowledged that low-quality images can lead to misdiagnoses. He explained that the greatest challenge was not only developing the AI models—trained on a diverse dataset of 11,000 ultrasounds—but also ensuring the technology operated reliably across various demographics with higher risks. “Given the documented disparities in healthcare outcomes, it was essential to prove consistent performance across different patient groups,” Bustami stated. The FDA clearance process took nearly three years, during which the team learned the importance of aligning engineering, product development, clinical validation, and regulatory strategies from the outset. With FDA approval now secured, Bustami shared that the company's next objective is to expand its reach across health systems nationwide. He is also looking to introduce additional features aimed at improving fetal medicine and reproductive health. “We are poised to enhance both distribution and clinical impact while further advancing our technology's capabilities,” he concluded.