BioticsAI secures FDA clearance for fetal ultrasound AI

BioticsAI announced on Monday that it has received clearance from the Food and Drug Administration (FDA), the U.S. medical device regulator, for its artificial intelligence software designed to detect fetal abnormalities in ultrasound images. The company was launched in 2021 by founder and CEO Robhy Bustami alongside co-founders Salman Khan, Chaskin Saroff, and Dr. Hisham Elgammal, aiming to improve prenatal care and reduce misdiagnosis rates in the U.S. Before securing this regulatory milestone, the startup won the TechCrunch Disrupt Battlefield competition in 2023.

The software utilizes computer vision AI to analyze ultrasound scans. According to Bustami, the technology is designed to support fetal ultrasound quality assessment, anatomical completeness, automated reporting, and seamless integration into clinical workflows. To achieve this, the company trained its AI models on a dataset consisting of hundreds of thousands of ultrasounds. This training is intended to address a vulnerability in prenatal care: while prenatal ultrasound imaging is the cornerstone of monitoring pregnancies, low-quality scans can lead to misdiagnosis.

Securing the regulatory clearance required just under three years of testing and validation. Bustami noted that the startup managed this timeline by avoiding sequential development, choosing instead to design the product, clinical validation, and regulatory pathway together from the very beginning rather than sequentially. By tightly aligning engineering, product, clinical, and regulatory workflows from the company’s inception, the team was able to move quickly through the FDA process.

The technology is entering a market defined by maternal health challenges. The U.S. has one of the worst prenatal outcomes for mothers among high-income nations, a crisis marked by maternal deaths. BioticsAI focused its validation on ensuring the software performed reliably across patient subgroups, particularly demographics facing 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, the company’s founder and CEO, said. Following the clearance, the company plans to scale its distribution and clinical impact across various health systems nationwide, positioning itself to expand its reach while continuing to deepen the power of its technology.

Why it matters

BioticsAI’s regulatory milestone highlights the growing role of computer vision AI in addressing critical gaps in prenatal care. By securing clearance, the company targets documented disparities in healthcare outcomes and aims to reduce misdiagnosis rates across diverse patient populations.