GI Genius

26% of polyps are missed. Every miss is a potential cancer.

Colorectal cancer is the second leading cause of cancer death in the US. Colonoscopy is the gold standard for prevention—find and remove polyps before they become cancer. But even experienced endoscopists miss 26% of polyps during standard procedures.

The technology existed to help: deep learning models could detect polyps in real-time video with high accuracy. But the path to clinical deployment was unclear. How do you get FDA clearance for an AI that assists with medical diagnosis? What evidence do you need? What documentation?

I advised on the technical and regulatory strategy. Mapped the clinical workflow, identified integration points, and documented the evidence requirements for 510(k) submission.

30 frames per second. Zero disruption to workflow.

The AI module connects between the endoscope and the display. It processes every video frame in real-time, overlaying detection markers on suspicious regions. The physician sees the same view they always have—plus AI assistance.

Architecture constraints: must work with existing equipment, must not add latency visible to the physician, must integrate with EHR for documentation, must maintain complete audit trail for regulatory compliance.

99.7% sensitivity. Validated in multi-center trials.

The model was trained on 13 million+ frames from over 5,000 procedures. Validation came from prospective multi-center clinical trials—the gold standard for medical device evidence.

Key to FDA clearance: comprehensive documentation of model performance, failure modes, and limitations. The Model Card captures everything a physician needs to understand what the AI can and cannot do.

From clearance to 500+ sites in 12 months.

FDA clearance was the beginning, not the end. Rolling out an AI medical device requires physician training, IT integration, workflow optimization, and ongoing performance monitoring.

Built deployment playbooks covering installation, training, and support. Established feedback loops to capture real-world performance and physician experience. Created dashboards tracking adoption and clinical outcomes.

The Result

GI Genius received FDA 510(k) clearance in April 2021—the first AI system cleared for real-time polyp detection during colonoscopy. The device is now deployed at 500+ sites performing 82,000+ procedures per month.

Clinical studies show a 14% improvement in adenoma detection rate (ADR) when using GI Genius. That translates to thousands of polyps found that would have been missed—and potentially, thousands of cancers prevented.