BioticsAI's Big Win: FDA Approval Secured

Image: Unsplash

BioticsAI, the 2023 TechCrunch Disrupt Battlefield champ, just scored FDA approval for its AI-driven fetal ultrasound tool.

Founded by Robhy Bustami, who grew up surrounded by obstetricians, BioticsAI aims to revolutionise prenatal care in the U.S., where maternal outcomes lag behind other high-income countries. Bustami, alongside co-founders Salman Khan, Chaskin Saroff, and Dr. Hisham Elgammal, launched the company in 2021. Their tech uses computer vision AI to enhance ultrasound quality, automate reporting, and integrate seamlessly into clinical workflows.

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The journey wasn't just about coding; it was about ensuring the AI's reliability across diverse demographics, particularly for those at higher risk, like Black women, who face higher maternal mortality rates. By aligning engineering, clinical, and regulatory efforts from the start, BioticsAI navigated the FDA process in under three years.

With FDA clearance in hand, BioticsAI is set to expand across U.S. health systems and add more features for fetal medicine. Bustami's vision is to scale both distribution and clinical impact, making their tech a game-changer in reproductive health. Keep your eyes on this rising star as they continue to innovate and transform prenatal care!

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