11/12/2025
CapsoVision today announced that it has submitted an application to the U.S. Food and Drug Administration on November 6, 2025 requesting Breakthrough Device Designation to accelerate development of the Company’s CapsoCam UGI capsule endoscopy system for use in early-stage pancreatic cancer detection.
This submission represents an important milestone in CapsoVision’s mission to expand its capsule-based diagnostics platform beyond the small bowel and address some of the most challenging diseases in gastroenterology.
Read more here: https://investors.capsovision.com/news-releases/news-release-details/capsovision-submits-breakthrough-device-designation-application