BioticsAI, a health tech startup founded in 2021, has recently received FDA regulatory clearance for its AI-powered fetal ultrasound platform. Named “Battlefield 2023,” the system is designed to assist medical professionals in evaluating pregnancy ultrasounds.
The project traces back to the family background of its founder, Robhy Bustami, who grew up surrounded by obstetrics specialists, including his mother, aunt, and uncle. From a young age, Bustami accompanied his mother on professional trips, gaining firsthand insight into the challenges of prenatal care in diverse communities.
After studying computer science at UC Irvine, Bustami joined forces in 2021 with Salman Khan, Chaskin Saroff, and Dr. Hisham Elgammal to create BioticsAI. Together, they developed a technology that uses advanced computer vision to analyze fetal ultrasound images, assess their technical quality, verify anatomical integrity, and generate preliminary reports that integrate directly into clinical systems.
The team’s core motivation is to help improve prenatal care outcomes in the United States, where—despite being a high-income nation—significant disparities in maternal health persist, especially in historically underserved communities.
According to Bustami, although prenatal ultrasound is essential in pregnancy monitoring, variability in image quality can affect diagnostic accuracy. BioticsAI’s technology aims to provide consistent support regardless of the clinical setting or patient demographic.
One of the biggest challenges, the founder explained, was not developing the AI models—trained on hundreds of thousands of diverse ultrasounds—but ensuring the system performed reliably under real-world conditions, particularly in populations at higher risk of obstetric complications.
The FDA clearance process took nearly three years and included extensive testing and validation. This experience taught the team the importance of aligning technical, clinical, and regulatory aspects from the outset, enabling more agile and impact-focused development.
Now with regulatory approval secured, BioticsAI plans to deploy its technology across various health systems nationwide. The company also intends to expand the platform’s functionality to address other areas of fetal medicine and reproductive health, aiming to scale both its distribution and clinical impact.
Article sponsored by: CMOSS Medical USA