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

Reuters
2025.12.29 21:05
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CapsoVision Inc. has submitted a 510(k) application to the FDA for an AI-assisted reading module for its CapsoCam Plus® capsule endoscopy system. This module aims to improve the detection of significant pathology and decrease clinician review time. CapsoVision intends to begin U.S. commercialization after receiving FDA clearance.