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Medical Devices / Regulatory Affairs

AI Medical Gets Breakthrough Device Designation for Endoscopic AI System

Nov. 13, 2019
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Japan-based AI Medical Service secured  breakthrough device designation from the FDA for its artificial intelligence programs that analyze endoscopy images for potential diagnosis of gastric cancer.

The system uses neural network algorithms trained with large real-world datasets of images of cancer lesions, benign lesions and normal tissue that were captured using standard endoscopes. The system also is able to detect gastric, colorectal and esophageal cancer.

The company’s CEO Tomohiro Tada said it will launch the technology in the U.S. market as soon as possible.

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