FDA grants de novo clearance to AnX Robotica’s AI tool for small bowel capsule endoscopy

The FDA has granted de novo clearance to AnX Robotica for its “groundbreaking” artificial intelligence-assisted reading tool to aid in small bowel capsule endoscopy procedures, according to a company release.
With this clearance, AnX Robotica’s NaviCam ProScan is the first AI-assisted reading tool intended to support endoscopy reviewers in identifying patients with suspected small bowel bleeding from small bowel capsule endoscopy images.
“As a clinician deeply immersed in the field of gastroenterology, I am thrilled to witness the FDA clearance of ProScan,”

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