CapsoVision Announces 510(k) Submission for the Addition of AI-Assisted Reading Module in CapsoCam Plus® (Globe Newswire)

CapsoVision has taken a key regulatory step toward expanding the role of AI in capsule endoscopy. The company announced the submission of an FDA 510(k) application for an AI-assisted reading module designed to enhance pathology detection and reduce clinician review time for its CapsoCam Plus system. Framed as part of a broader push toward cloud-based, AI-enabled GI diagnostics, the move highlights how capsule endoscopy platforms are evolving beyond image capture alone. Whether this approach meaningfully reshapes small-bowel workflows—and how it compares with existing solutions—becomes clearer in the full announcement from CapsoVision.