CapsoVision Submits 510(k) Application for AI-Assisted Capsule Endoscopy Module

Reuters2025-12-30

CapsoVision Submits 510(k) Application for AI-Assisted Capsule Endoscopy Module

CapsoVision Inc. has announced the submission of its 510(k) application to the U.S. Food and Drug Administration (FDA) for an AI-assisted reading module for its CapsoCam Plus® capsule endoscopy system. The new module is designed to enhance the detection of clinically significant pathology and reduce clinician review time. CapsoVision plans to commence U.S. commercialization activities following FDA clearance.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Capso Vision Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 9617871) on December 29, 2025, and is solely responsible for the information contained therein.

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