CapsoVision has filed for FDA Breakthrough Device Designation for its CapsoCam UGI capsule endoscopy system — a swallowable camera designed to detect pancreatic ductal adenocarcinoma at earlier, treatable stages. Unlike traditional imaging or invasive endoscopy, the device offers a completely non-invasive, panoramic view of the duodenal papilla, where subtle structural changes may reveal pancreatic disease.
If granted, the designation would fast-track collaboration with the FDA and accelerate clinical validation. With pancreatic cancer’s 5-year survival rate lingering near 10% and most diagnoses made too late for surgery, a screening capsule could mark a turning point in detection. CapsoVision’s platform already powers small bowel and upcoming colon imaging systems, signaling a future where GI diagnostics move from scopes to smart pills.