TechCrunch Disrupt Battlefield 2023 winner BioticsAI announced Monday that it has received FDA approval for its artificial intelligence software that helps detect fetal abnormalities in ultrasound images.
The product was envisioned by founder, CEO Robhy Bustami, who grew up in a family of obstetricians, including his mother, aunt and uncle. He spent a lot of time in hospitals growing up, traveling often with his mother as she provided maternal care throughout the US
After learning to code and studying computer science at UC Irvine, Bustami worked with Salman Khan, Chaskin Saroff and Dr. Hisham Elgammal in 2021 to start BioticsAI.
The technology uses computer vision artificial intelligence “to support fetal ultrasound quality assessment, anatomical completeness, automated reporting and seamless integration into clinical workflows,” Bustami told TechCrunch.
He hopes his technology will help the U.S. combat the fact that the U.S. has one of the worst prenatal outcomes for mothers among high-income countries. Black women in particular face a very high rate of maternal deaths,
Bustami said prenatal ultrasound has become the “cornerstone” of monitoring pregnancies, but low-quality images can lead to misdiagnosis.
Bustami said the hardest part wasn’t building his AI models, which were trained on a diverse set of hundreds of thousands of ultrasounds, but making sure the technology performed reliably in the real world, especially in demographics at the highest risk for a tragic outcome.
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“In an environment where disparities in health care outcomes are well documented, it was critical to demonstrate consistent performance across patient subgroups, not just idealized cases,” Bustami continued.
The CEO said it took just three years to go through the FDA process, including product testing and validation. The experience taught him and his team how important it is to tightly align engineering, product, clinical and regulatory work from the start. “By designing the product, clinical validation and regulatory pathway together, rather than sequentially, we were able to move forward quickly,” he said.
Now with FDA clearance, Bustami said the companies’ next focus is scaling up to various health systems nationwide. It also has plans to add more features on fetal medicine and reproductive health.
“We are able to scale both distribution and clinical impact while continuing to deepen the power of our technology,” he said.
This piece has been updated to correct the spelling of the co-founder’s name.
