Biotics AI Emerges as a Leader in Prenatal Technology with FDA Clearance
TechCrunch Disrupt Battlefield 2023 winner, Biotics AI, announced on Monday that it has received FDA clearance for its AI software that helps detect fetal abnormalities in ultrasound images.
The vision behind Biotics AI stems from founder and CEO Robhy Bustami, who was raised in a family of obstetricians. Growing up surrounded by maternal care, Bustami was often found in hospitals, traveling with his mother as she provided essential services throughout the United States. This early exposure to healthcare laid the foundation for his dedication to improving maternal and fetal outcomes.
A Journey from Coding to Healthcare Innovation
After honing his programming skills and earning a computer science degree from UC Irvine, Bustami joined forces with a talented team—Salam Khan, Chaskin Saroff, and Dr. Hisham Elgammal—to launch Biotics AI in 2021. Their collective expertise has been pivotal in developing a product that leverages computer vision technology to enhance fetal ultrasound quality.
Bustami explained that the software offers features such as anatomical completeness, automated reporting, and seamless integration into clinical workflows. “Our technology aims to support healthcare providers effectively,” he noted, emphasizing the potential impact on prenatal care.
Tackling Inequities in Prenatal Outcomes
As Bustami pointed out, the U.S. grapples with troubling prenatal outcomes, particularly among Black women, who face significantly higher maternal mortality rates. He described prenatal ultrasounds as the “cornerstone” of monitoring pregnancies but acknowledged that low-quality images often lead to misdiagnoses.
The challenge for Biotics AI was not just developing AI models—trained on an extensive and diverse dataset of 11,000 ultrasounds—but ensuring their reliability across various demographics. “It was crucial to demonstrate consistent performance across patient subgroups, not just in idealized cases,” he stated.
Navigating the FDA Approval Process
Achieving FDA clearance was no small feat; Bustami shared that the company dedicated just under three years to this comprehensive process, including rigorous testing and validation of the product. The experience highlighted the importance of closely coordinating engineering, product development, clinical validation, and regulatory pathways from the outset. “By designing the product alongside clinical and regulatory validation, we accelerated our progress,” he recalled.
Future Aspirations for Biotics AI
Now that Biotics AI has secured FDA clearance, Bustami’s vision is to scale its technology across health systems nationwide. Plans are also underway to enhance features targeted at fetal medicine and reproductive health, positioning the company at the forefront of this vital sector in healthcare.
“We’re poised to scale both distribution and clinical impact while continuing to deepen the power of our technology,” Bustami stated, reflecting optimism for the future of prenatal care.
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