GI Genius
Medtronic
The first FDA-authorized AI device for real-time computer-aided polyp detection, overlaying markers on the live endoscopic video during colonoscopy.
At A Glance
- Manufacturer
- Medtronic
- Medical specialty
- Gastroenterology
- Clearance route
- De Novo
- Year authorized
- 2021
- Modality
- Colonoscopy video
- Role in workflow
- Real-time detection
Every other device here works on a stored study. This one works on live video while a procedure is in progress, which changes the failure consequence: a missed frame is a missed lesion in a patient who is currently sedated on a table, and the endoscopist cannot re-read the exam later.
Adenoma detection rate varies enormously between endoscopists and is directly linked to interval cancer risk. Compressing that variability is a stronger argument than raising any individual endoscopist's ceiling.
Where It Is Used
- Adenoma detection rate improvement
- Screening and surveillance colonoscopy
- Reducing endoscopist-to-endoscopist variability in detection
Limitations Worth Knowing
Detection is not characterization: the device marks a lesion without telling the endoscopist whether it needs removal. Increased detection of small non-advanced adenomas raises procedure time and surveillance burden, and whether that translates into fewer cancers is still being established. Sustained real-world benefit also depends on endoscopists continuing to attend to the overlay rather than habituating to it.
Regulatory status, indications, and labeling change over time. Confirm current status on the FDA's AI/ML-Enabled Medical Devices list and in the manufacturer's current instructions for use before relying on anything stated here.