MobiHealth News April 12, 2021
Mallory Hackett

The system identifies potentially dangerous lesions during colonoscopies – but is not intended to diagnose or instruct on next steps.

The Food and Drug Administration has granted De Novo authorization to GI Genius, the first-of-its-kind device that uses artificial intelligence to help clinicians identify polyps in real time during colonoscopies.

Manufactured by Cosmo Pharmaceuticals and distributed by Medtronic, the GI Genius software and hardware can be applied to most colonoscopy videos to assist in the detection of precancerous lesions.

During a colonoscopy, the AI-enabled system places green squares around potential lesions and alerts clinicians with a low-volume sound signaling that further examination may be needed.

The system is not intended to diagnose or instruct clinicians on how to manage suspicious...

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Topics: AI (Artificial Intelligence), FDA, Govt Agencies, Medical Devices, Provider, Technology
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