BioticsAI Secures FDA Clearance for AI-Driven Fetal Ultrasound Technology
By Cyprus Business Group News
From Disrupt Battlefield to Regulatory Milestone
BioticsAI, the winner of the TechCrunch Disrupt Battlefield 2023, has reached a major regulatory milestone. The healthtech startup announced on Monday that it has received U.S. Food and Drug Administration (FDA) clearance for its artificial intelligence software designed to assist in detecting fetal abnormalities through ultrasound imaging.
The clearance marks a significant step forward for the company as it moves from innovation-stage recognition to large-scale clinical deployment.
A Founder’s Personal Connection to Maternal Care
The idea behind BioticsAI was shaped by the personal background of founder and CEO Robhy Bustami, who grew up immersed in the medical world. Raised in a family of obstetricians — including his mother, aunt, and uncle — Bustami spent much of his childhood in hospitals and frequently traveled alongside his mother as she delivered maternal healthcare across the United States.
After learning to code and earning a computer science education at UC Irvine, Bustami co-founded BioticsAI in 2021 alongside Salman Khan, Chaskin Saroff, and Dr. Hisham Elgammal, combining clinical insight with advanced AI engineering.
How the Technology Works
BioticsAI’s platform applies computer vision and machine learning to improve the reliability and consistency of prenatal ultrasound examinations. As Bustami explained to TechCrunch, the software is designed:
“to support fetal ultrasound quality assessment, anatomical completeness, automated reporting, and seamless integration into clinical workflows.”
The goal is to assist clinicians by improving image interpretation, reducing human error, and ensuring that critical anatomical markers are consistently captured during scans.
Addressing Critical Gaps in Prenatal Outcomes
Bustami has been vocal about the broader healthcare challenge his company aims to address. Despite its advanced healthcare system, the United States continues to report some of the worst prenatal outcomes among high-income countries, with Black women facing disproportionately high maternal mortality rates.
According to Bustami, prenatal ultrasound has become the “cornerstone” of pregnancy monitoring, yet image quality and variability can still lead to misdiagnosis or missed complications.
Building AI That Works in the Real World
While developing the AI models was a complex task, Bustami said the greater challenge was ensuring consistent real-world performance. The models were trained on a diverse dataset of hundreds of thousands of ultrasound scans, but clinical reliability across different populations remained critical.
“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 said.
Ensuring accuracy for higher-risk demographics was a central focus throughout development and validation.
Navigating the FDA Approval Process
BioticsAI’s path to FDA clearance took just under three years, encompassing extensive testing, clinical validation, and regulatory review. The process reshaped how the company approached product development.
Bustami noted that the experience reinforced the importance of early alignment across teams:
“By designing the product, clinical validation, and regulatory pathway together, rather than sequentially, we were able to move quickly.”
This integrated approach allowed the startup to streamline approvals while maintaining regulatory rigor.
What Comes Next for BioticsAI
With FDA clearance secured, BioticsAI is now focused on scaling deployment across health systems nationwide. The company is also planning to expand its platform with additional features aimed at fetal medicine and reproductive health.
“We’re positioned to scale both distribution and clinical impact while continuing to deepen the power of our technology,” Bustami said.
As AI adoption accelerates in healthcare, BioticsAI’s progress highlights how clinical insight, responsible AI development, and regulatory readiness can converge to create meaningful impact.
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