CapsoVision, a medical device developer, submitted an application Nov. 6 to the FDA requesting breakthrough device designation for its CapsoCam UGI capsule, aimed at detecting early-stage pancreatic cancer.
The device offers panoramic imaging of the upper gastrointestinal tract and enables visualization of the duodenal papilla — a structure linked to early pancreatic changes — via a pill-sized, noninvasive camera, according to a Nov. 10 news release.
The device is intended to address the absence of populationwide screening tools for pancreatic ductal adenocarcinoma, the most common form of pancreatic cancer, which has an 8% five-year survival rate. CapsoVision said identifying abnormalities in the duodenal papilla could offer earlier insight into disease.
If granted, breakthrough device designation would allow CapsoVision to work more closely with the FDA on device development, clinical trials and regulatory review, according to the release.
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