TechCrunch is annoying Battlefield 2023 winner, Biotics AIannounced on Monday that it had received FDA clearance for its AI software which helps detect fetal abnormalities in ultrasound images.
The product was envisioned by founding CEO Robhy Bustami, who was raised in a family of obstetricians, including his mother, sister, and uncle. She spent a lot of time in hospitals growing up, often traveling with her mother as she provided maternity care throughout the US
After studying code and studying computer science at UC Irvine, Bustami collaborated with Salam Khan, Chaskin Saroff, and Dr. Hisham Elgammal in 2021 to launch. Biotic AI,
The technology uses AI computer vision “to support fetal ultrasound quality assessment, anatomical completeness, automated reporting, and seamless integration into clinical workflows,” Bustami told TechCrunch.
She hopes the 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 extremely high rates of maternal mortality,
Bustami said prenatal ultrasounds have become a “foundation” for pregnancy monitoring, but low-quality images can lead to misdiagnosis.
Bustami said the hardest part was not building the AI model, which was trained on a variety of 11,000 ultrasounds, but ensuring the technology was reliable in the real world, especially in the demographics at highest risk for tragic outcomes.
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“In an environment where differences in health care outcomes are well documented, it is important to demonstrate consistent performance in subgroups of patients, not just in appropriate cases,” Bustami said.
The CEO said it only took three years to go through the FDA process, including testing and validating the product. That experience taught him and his team the importance of engineering, product, clinical, and regulatory alignment from the start. “By designing the product, clinical validation, and regulatory pathway together, rather than sequentially, we can move quickly,” he said.
Now with FDA clearance, Bustami said the company’s next focus is to scale across multiple healthcare systems nationwide. They also have plans to add more features for fetal medicine and reproductive health.
“We’re positioned to measure both distribution and clinical impact while continuing to deepen the power of our technology,” he said.