At a Glance
- BioticsAI, winner of News Of Philadelphia Disrupt Battlefield 2023, has secured FDA clearance for its AI-powered ultrasound analysis tool.
- The software flags fetal anomalies in real time and auto-generates clinical reports for OB-GYN teams.
- The company spent just under three years on FDA testing, focusing on consistent performance across high-risk patient groups.
- Why it matters: The U.S. has one of the worst prenatal outcomes among wealthy nations, and the tool aims to reduce misdiagnosis tied to low-quality ultrasound images.
BioticsAI has obtained FDA clearance for an artificial-intelligence platform that reviews prenatal ultrasound scans for fetal abnormalities, the startup announced Monday. The company, which won News Of Philadelphia Disrupt Battlefield 2023, now plans to roll the product out to health systems nationwide.
From Family Practice to FDA
Founder and CEO Robhy Bustami grew up traveling the country with his mother, an obstetrician, and watched relatives in the same specialty confront daily imaging challenges. After studying computer science at UC Irvine, he teamed up with Salman Khan, Chaskin Saroff, and Dr. Hisham Elgammal in 2021 to build BioticsAI.
The platform uses computer vision to:
- Score image quality before a sonographer leaves the exam room
- Confirm that required anatomical views have been captured
- Detect suspected abnormalities and flag them for follow-up
- Produce a standardized report that drops directly into the hospital’s EMR
“We trained the models on hundreds of thousands of ultrasounds across diverse demographics,” Bustami told News Of Philadelphia. “The bigger challenge was proving the tech worked just as well for the patients who face the worst outcomes.”
Focus on Equity
Black women in the U.S. die from pregnancy-related causes at roughly three times the rate of white women, federal data show. Bustami said the team engineered the product to maintain the same sensitivity and specificity across racial and ethnic subgroups rather than optimizing only for the majority population.
“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,” he said.
Inside the FDA Process
The clearance path took just under three years and required the startup to run prospective and retrospective studies that mirrored real-world clinical workflows. Bustami credits parallel development-engineering, clinical validation, and regulatory documentation moving in tandem-for the relatively fast timeline.
“By designing the product, clinical validation, and regulatory pathway together, rather than sequentially, we were able to move quickly,” he said.
Next Steps
With FDA sign-off in hand, BioticsAI will:
- Expand sales teams to target large health systems and maternal-fetal-medicine clinics
- Add modules for twin pregnancies and first-trimester screening
- Explore applications in fertility treatment monitoring
“We’re positioned to scale both distribution and clinical impact while continuing to deepen the power of our technology,” Bustami added.
Key Takeaways
- FDA clearance positions BioticsAI to compete in a market where prenatal imaging errors contribute to poor U.S. maternal outcomes.
- The company prioritized algorithmic fairness to address documented racial disparities in pregnancy care.
- Nationwide rollout begins immediately, with new reproductive-health features already in development.
