(DumbMoney)

Explore the latest updates and key analyses on companies, markets, and industry trends.


CapsoVision Submits 510(k) Application for AI-Assisted Reading Module in CapsoCam Plus®

CapsoVision (CV) | December 29, 2025

By Victor Perez

image

CapsoVision, Inc. announced the submission of its 510(k) application to the FDA for an AI-assisted reading module for CapsoCam Plus®.

The new module aims to enhance the detection of clinically significant pathology and reduce clinician review time.

The company is preparing for U.S. commercialization activities following FDA clearance.

Innovative Technology

CapsoVision is developing advanced imaging and AI-enabled solutions in the medical technology sector.

AI Integration

The AI-assisted reading module for CapsoCam Plus® aims to improve diagnostic capabilities and streamline clinical workflows.

Market Potential

CapsoVision's focus on gastrointestinal disease detection shows potential for growth across multiple indications.

  • The addition of AI technology in healthcare diagnostics is set to revolutionize the industry by enhancing accuracy and efficiency.
  • CapsoVision's unique approach, combining advanced imaging with AI interpretation, positions the company as a leader in capsule endoscopy solutions.

CapsoVision's 510(k) submission marks a significant step towards offering cutting-edge diagnostic solutions in the medical field, reflecting the company's commitment to innovation and patient care.