**Big News: Biotics AI’s Revolutionary Fetal Ultrasound Tech Gets FDA Clearance**
Hey everyone, I just got word that Biotics AI, the company that stole the show at TechCrunch Disrupt Battlefield 2023, has finally received FDA clearance for its groundbreaking AI-powered fetal ultrasound technology. This is a huge deal, folks, and I’m stoked to share the story of how it all came together.
For those who may not know, Biotics AI’s CEO, Robhy Bustami, has a pretty personal connection to this space. Growing up, he spent countless hours in hospitals with his mom, who was an obstetrician. He saw firsthand the work that went into helping new moms and dads navigate the medical system. And that’s exactly what sparked his passion for creating Biotics AI.
After studying computer science at UC Irvine and learning to code, Bustami teamed up with a talented crew – Salam Khan, Chaskin Saroff, and Dr. Hisham Elgammal – to bring his vision to life in 2021. Their AI-powered software uses computer vision to review fetal ultrasound quality, detect anatomical completeness, automate reporting, and integrate seamlessly into medical workflows.
The goal is ambitious: to help the US improve its prenatal outcomes, which are pretty concerning, especially when compared to other high-income countries. Black women, sadly, are disproportionately affected, facing a much higher maternal mortality rate.
Bustami believes that the prenatal ultrasound has become a cornerstone of pregnancy monitoring, but when ultrasound images are of poor quality, it can lead to misdiagnosis. So, he and his team trained their AI models on over 11,000 ultrasounds to tackle this issue. But the real challenge was ensuring that their tech could perform under real-world conditions, especially for populations at high risk.
After a rigorous FDA process, including testing and validation, Biotics AI’s product has finally gotten the green light. The next step? Scaling their solution across the US, and adding more features to support fetal medicine and reproductive health.
“We’re not just scaling our distribution – we’re scaling our medical impact, and deepening the power of our technology,” Bustami said in a statement.
I’m keeping a close eye on Biotics AI’s progress, and I’m excited to see how their innovative tech will make a difference in maternal healthcare.
**Source:** [Biotics AI’s AI-powered fetal ultrasound product gains FDA approval](https://techcrunch.com/2026/01/19/biotics-ai-battlefield-2023-gains-fda-approval-for-its-ai-powered-fetal-ultrasound-product/)
