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

SARATOGA, Calif., Dec. 29, 2025 (GLOBE NEWSWIRE) -- CapsoVision, Inc. (NASDAQ: CV), a commercial-stage medical technology company developing advanced imaging and AI-enabled capsule endoscopy solutions, today announced submission of its 510(k) application to the Food and Drug Administration (FDA) for its proprietary AI-assisted module for CapsoCam Plus®. The addition of this reading tool will improve the detection of clinically significant pathology, as well as reduce clinician review time. The Company intends for U.S. commercialization activities to commence after the FDA clearance.