CapsoVision files FDA Breakthrough Device application for pancreatic cancer screening capsule

CapsoVision, Inc

Submitted BDD application to FDA on Nov 6, 2025 for CapsoCam UGI capsule to detect early-stage pancreatic ductal adenocarcinoma.
If granted, the designation would enable accelerated development and closer FDA collaboration on clinical studies.
CapsoCam UGI is a non-invasive, pill-shaped camera with panoramic imaging to visualize duodenal papilla changes.
Pancreatic cancer has 8-10% five-year survival rate; no non-invasive screening exists for the general population.

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