Biotics AI game, Battlefield 2023, receives FDA approval for AI-powered fetal ultrasound product

Biotics AI, winner of the 2023 TechCrunch Disrupt Battlefield Award, announced Monday that it has received Food and Drug Administration (FDA) approval for its AI software that helps detect fetal abnormalities in ultrasound images.

The product was conceived by founder and CEO Robbie Bustami, who grew up in a family of obstetricians, including his mother, sister and uncle. He spent a lot of time in hospitals growing up, often traveling with his mother as she provided maternity care throughout the United States

After learning programming and studying computer science at UC Irvine, Bastami teamed up with Salam Khan, Chaskin Saroff, and Dr. Hisham El Gamal in 2021 to launch Biotics AI,

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

He hopes his technology will help the United States combat the fact that the United States has one of the worst prenatal outcomes for mothers among high-income countries. Black women in particular face a very high rate of maternal mortality,

Bastami said that prenatal ultrasound has become a “cornerstone” in monitoring pregnancies, but its low-quality images can lead to incorrect diagnosis.

Bustami said the hardest part was not building its AI models, which were trained on a variety of 11,000 ultrasound images, but ensuring the technology performed reliably in the real world, especially with the demographics most at risk of a tragic outcome.

“In an environment where disparities in healthcare outcomes are well documented, it was essential to demonstrate consistent performance across subgroups of patients, not just in ideal cases,” Bastami continued.

The CEO said it took less than three years to go through the FDA process, including testing and validation of the product. This experience taught him and his team how important it is for the engineering, product, clinical and regulatory businesses to be closely aligned from the beginning. “By designing the product, clinical validation and regulatory pathway together, rather than sequentially, we were able to move quickly,” he said.

Now that it has received FDA approval, Bustami said the companies’ next focus is expanding across different health systems nationwide. He also plans to add more features for fetal medicine and reproductive health.

“We are positioned to expand distribution and clinical impact while continuing to deepen the strength of our technology,” he said.