BioticsAI FDA Clearance for AI Fetal Abnormality Detection Software
BioticsAI has secured FDA clearance for its AI-powered fetal abnormality detection software. The 2023 TechCrunch Disrupt winner aims to combat U.S. maternal health disparities through automation.
The U.S. faces a growing maternal health crisis with some of the worst outcomes among high-income nations. Now, BioticsAI, the winner of TechCrunch Disrupt Battlefield 2023, is deploying its computer vision technology to the front lines after receiving FDA clearance for its fetal abnormality detection software.
Scaling BioticsAI FDA Clearance for Maternal Health
The software is designed to support fetal ultrasound quality assessment and automated reporting. CEO Robhy Bustami, who grew up in a family of obstetricians, founded the company in 2021 to address the frequent misdiagnoses caused by low-quality ultrasound images.
In an environment where disparities in healthcare outcomes are well documented, it was critical to demonstrate consistent performance across patient subgroups.
Key Specs and Availability
| Feature | Detail |
|---|---|
| Core Technology | Computer Vision AI for Ultrasound |
| Training Data | Hundreds of thousands of diverse scans |
| FDA Process Time | Under 3 years |
| Target Launch | Nationwide health systems in 2026 |
| Price | Price Undisclosed (B2B) |
BioticsAI's next focus is scaling across various health systems nationwide. The team also plans to deepen the technology's power by adding more features for reproductive health and fetal medicine.
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