TechCrunch Disrupt Battlefield 2023 winner, BioticsAI, announced on Monday that it has received FDA clearance for its AI software that helps detect fetal abnormalities in ultrasound images. 

The product was envisioned by founder CEO Robhy Bustami, who was raised in a family of obstetricians, including his mother, aunt and uncle. He spent a lot of time in hospitals growing up, often traveling with his mother as she provided maternal care throughout the U.S.  

After learning to code and studying computer science at UC Irvine, Bustami teamed up with Salman Khan, Chaskin Saroff, and Dr. Hisham Elgammal in 2021 to launch BioticsAI.

The technology uses computer vision AI “to support fetal ultrasound quality assessment, anatomical completeness, automated reporting, and seamless integration into clinical workflows,” Bustami told TechCrunch. 

He hopes his tech will help the U.S. combat the fact that the U.S. has 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 hundreds of thousands of ultrasounds, but ensuring the tech 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,” Bustami continued.  

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, we were able to move quickly,” he said.  

Now with FDA clearance, Bustami said the companies’ next focus is scaling across various health systems nationwide. He also has plans to add more features for fetal medicine and reproductive health. 

“We’re positioned to scale both distribution and clinical impact while continuing to deepen the power of our technology,” he said.  

This piece was updated to correct the spelling of the co-founder’s name.

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