According to AIbase, the medical technology startup BioticsAI, which won the 2023 TechCrunch Disrupt competition, officially announced on January 19, 2026, that its self-developed artificial intelligence software has been approved by the U.S. Food and Drug Administration (FDA). The software is designed to help doctors detect fetal abnormalities in ultrasound images using AI technology, significantly improving the accuracy of prenatal screening.

AI Medical

Vision-Driven: From a Family of Obstetricians to an AI Lab

The creation of BioticsAI was deeply influenced by the background of its founder and CEO Robhy Bustami. Bustami grew up in a family of obstetricians, with his mother and several relatives working in this field. While studying computer science at the University of California, Irvine, he realized that although ultrasound examinations are the cornerstone of prenatal monitoring, the high misdiagnosis rate caused by inconsistent image quality remained a problem, which inspired him to establish BioticsAI in 2021.

Core Technology: Real-Time Error Correction and Process Automation

This technology uses advanced computer vision algorithms, playing three key roles in clinical operations:

  • Quality Assessment and Anatomical Integrity Check: It monitors the ultrasound scanning process in real time, ensuring that doctors capture all necessary anatomical views and preventing missed diagnoses.

  • Automated Report Generation: It automatically extracts key measurement data and seamlessly integrates with clinical workflows, reducing the administrative burden on medical staff.

  • Reliability Across Populations: The model is trained on hundreds of thousands of diverse ultrasound images, with a particular focus on improving diagnostic performance in high-risk and often overlooked groups such as Black women, aiming to address the growing disparities in maternal mortality rates in the United States.

Regulatory Journey: A Winning Strategy of Synchronized Design

BioticsAI's FDA approval process lasted nearly three years. Bustami pointed out that the key to success lay in a non-linear R&D approach. Instead of following the traditional model of "develop first, validate later, then regulate," the company tightly integrated engineering, clinical validation, and regulatory requirements from day one. This synchronized design strategy ensured that the product maintained a high level of consistency and effectiveness in the complex and ever-changing medical environment.

Future Outlook: Scaling and Function Expansion