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CapsoVision Seeks FDA Breakthrough Status for CapsoCam

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CapsoVision Seeks FDA Breakthrough Status for CapsoCam

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CapsoVision, Inc. ( (CV) ) just unveiled an announcement.

On November 10, 2025, CapsoVision announced the submission of an application to the FDA for Breakthrough Device Designation for its CapsoCam UGI capsule endoscopy system, aimed at early-stage pancreatic cancer detection. This non-invasive technology could significantly impact the early diagnosis of pancreatic ductal adenocarcinoma, one of the deadliest cancers, by providing a patient-friendly alternative to current invasive diagnostic methods. If granted, the designation would expedite the development process and potentially improve survival rates by enabling earlier detection and treatment.

The most recent analyst rating on (CV) stock is a Buy with a $7.00 price target. To see the full list of analyst forecasts on CapsoVision, Inc. stock, see the CV Stock Forecast page.

Spark’s Take on CV Stock

According to Spark, TipRanks’ AI Analyst, CV is a Neutral.

CapsoVision, Inc. has a low overall stock score primarily due to its poor financial performance, which is a significant concern. The technical analysis provides some positive momentum, but the lack of valuation data limits a comprehensive assessment. The absence of earnings call and corporate events data further constrains the evaluation.

To see Spark’s full report on CV stock, click here.

More about CapsoVision, Inc.

CapsoVision, Inc. is a commercial-stage medical technology company focused on developing advanced imaging and AI-enabled solutions to transform the detection and diagnosis of gastrointestinal diseases. Its flagship product, CapsoCam Plus®, is a wire-free, panoramic capsule endoscope that enables high-resolution visualization of the small bowel and supports cloud-based or direct capsule video retrieval. The company is expanding its proprietary platform to include multiple GI indications, including esophageal and pancreatic disorders.

Average Trading Volume: 35,211

Technical Sentiment Signal: Strong Buy

Current Market Cap: $221.2M

See more insights into CV stock on TipRanks’ Stock Analysis page.

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