CapsoVision Submits Breakthrough Device Designation Application to FDA for Pancreatic Cancer Screening Capsule
CapsoVision, Inc. (CV)
Company Research
Source: GlobeNewswire
SARATOGA, Calif., Nov. 10, 2025 (GLOBE NEWSWIRE) -- CapsoVision, Inc. (NASDAQ: CV), a commercial-stage medical technology company developing advanced imaging and AI-enabled capsule endoscopy solutions, today announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) on November 6, 2025 requesting Breakthrough Device Designation (BDD) 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. Pancreatic ductal adenocarcinoma — the most common form of pancreatic cancer — is among the deadliest cancers worldwide, with a five-year survival rate of only 8%, largely because it is diagnosed at advanced stages that cannot be treated. Currently, no early screening tools
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CV
News
- CapsoVision (NASDAQ:CV) had its "sell (e)" rating reaffirmed by analysts at <a style="font-weight:bold" href="https://weissratings.com/">Weiss Ratings</a>.MarketBeat
- CapsoVision (NASDAQ:CV) had its "sell (e)" rating reaffirmed by analysts at <a style="font-weight:bold" href="https://weissratings.com/">Weiss Ratings</a>.MarketBeat
- CapsoVision (NASDAQ:CV) had its "sell (e)" rating reaffirmed by analysts at <a style="font-weight:bold" href="https://weissratings.com/">Weiss Ratings</a>.MarketBeat
- CapsoVision to Participate in the Benchmark 14th Annual Discovery Investor Conference [Yahoo! Finance]Yahoo! Finance
- CapsoVision to Participate in the Benchmark 14th Annual Discovery Investor ConferenceGlobeNewswire
CV
Earnings
- 11/13/25 - Miss
CV
Sec Filings
- 11/12/25 - Form SCHEDULE
- 11/10/25 - Form 8-K
- 11/3/25 - Form 4
- CV's page on the SEC website