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CapsoVision Submits FDA 510(k) for AI-Assisted Module in CapsoCam Plus
Read MoreHide Full Article
Key Takeaways
CapsoVision filed a 510(k) to add AI-assisted reading to CapsoCam Plus to improve reviews and accuracy.
CV says its AI, panoramic imaging and cloud platform reduce clinician workload and operating costs.
Shares of CapsoVision fell 7.7% after the update despite a 205.4% surge over the past six months.
CapsoVision, Inc. (CV - Free Report) recently announced that it has submitted a 510(k) application to the FDA for approval to add an AI-based reading feature to its CapsoCam Plus capsule endoscopy system. The proposed AI feature is designed to improve the image review process, enhance diagnostic accuracy and improve workflow efficiency for clinicians. Upon FDA clearance, the company plans to commence selling the upgraded product in the United States.
Per management, FDA submission is an important step in CV’s goal to deliver a capsule endoscopy solution that uses advanced AI-based imaging to diagnose small intestine conditions. The company believes that the combination of advanced imaging, in-house AI models and fully cloud-based systems positions CapsoCam Plus as a next-generation solution for small bowel diagnostics and GI practices of all sizes.
CV Stock Trend Following the News
Shares of CapsoVision declined 7.7% since the announcement on Monday. Over the past six months, shares of the company have soared 205.4% compared with the industry’s 0.6% growth and the S&P 500’s 12.7% rise.
In the long run, FDA clearance and the addition of an AI-assisted reading tool to CapsoCam Plus enhance CapsoVision’s ability to address two major pain points in GI diagnostics — lengthy image review processes and variability in the detection and diagnosis of gastrointestinal diseases. This development supports wider adoption of AI-enabled medical imaging among gastroenterology practices and improves the company’s competitive positioning in the fast-developing field of AI-powered medical diagnostics.
CV currently has a market capitalization of $580.39 million.
Image Source: Zacks Investment Research
More on the AI-Assisted CapsoCam Plus
CapsoCam Plus AI feature is designed to visualize inside the small intestine to find medical problems in adults and children aged two years and older by capturing comprehensive panoramic images of the gastrointestinal tract. Its AI-assisted system is more advanced than competing products because it captures clearer images of the digestive tract to highlight areas that may need attention, saves time by reducing the chance of missing problems and overall offers an easier experience for both doctors and patients.
CapsoVision’s AI-assisted reading module leverages its in-house image dataset to identify clinically significant pathology, improve diagnostic reading accuracy while reducing clinician review burden. The growing collection of high-quality medical images helps train advanced AI models and discover new clinical insights, making CV’s AI-enabled diagnostic platform stand out from competitors.
CapsoVision’s fully cloud-based system prevents the need for on-site servers, lowers upfront costs, reduces downtime and removes IT maintenance requirements for GI practices by offering a diagnostic platform that is easier to use and more accurate. Together, an AI-upgraded and cloud-based deployment strengthens CapsoVision’s long-term growth strategy, positioning the company to benefit from growing capsule-based GI diagnostics.
Industry Prospects Favoring the Market
Going by data provided by Precedence Research, the capsule endoscopy market is valued at $479.13 million in 2025 and is expected to witness a CAGR of 7.95% through 2034. Factors like the rising adoption of minimally invasive diagnostics in gastrointestinal care, AI-enabled image interpretation, increasing use of capsule endoscopy in pediatric and geriatric populations and growing clinical trials validating capsule endoscopy for oncology screening are driving market growth.
Other News
In November 2025, CapsoVision announced that it had applied to the FDA for Breakthrough Device Designation to speed up the development of its CapsoCam UGI capsule. This non-invasive capsule endoscopy system is designed to detect early-stage pancreatic ductal adenocarcinoma, aiming to improve outcomes for one of the deadliest cancers worldwide.
The company is also working on its pipeline product, CapsoCam Colon, with advanced AI to allow non-invasive imaging of the colon and help detect polyps.
Some better-ranked stocks from the broader medical space are Omnicell (OMCL - Free Report) , CareCloud and Schrodinger (SDGR - Free Report) .
Omnicell, sporting a Zacks Rank #1 (Strong Buy) at present, reported third-quarter 2025 adjusted earnings per share (EPS) of 51 cents, which surpassed the Zacks Consensus Estimate by 41.7%. Revenues of $311 million beat the Zacks Consensus Estimate by 5.6%. You can see the complete list of today’s Zacks #1 Rank stocks here.
OMCL has an estimated long-term earnings growth rate of 9.4% compared with the industry’s 27.9% rise. The company beat earnings estimates in the trailing four quarters, the average surprise being 38.65%.
CareCloud, currently carrying a Zacks Rank #2 (Buy), reported a third-quarter 2025 adjusted EPS of 10 cents, which surpassed the Zacks Consensus Estimate by 25%. Revenues of $31.1 million beat the Zacks Consensus Estimate by 8.3%.
CCLD has an estimated earnings recession rate of 45.3% for 2025 against the industry’s 20.1% growth. The company missed earnings estimates in the trailing four quarters, the average surprise being 2.88%.
Schrodinger, currently carrying a Zacks Rank #2, reported a third-quarter 2025 loss per share of 45 cents, narrower than the Zacks Consensus Estimate by 40%. Revenues of $54.3 million beat the Zacks Consensus Estimate by 8.7%.
SDGR has an estimated long-term earnings growth rate of 37.8% compared with the industry’s 27.9% growth. The company’s earnings have missed estimates in the trailing four quarters, the average surprise being 0.93%.
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CapsoVision Submits FDA 510(k) for AI-Assisted Module in CapsoCam Plus
Key Takeaways
CapsoVision, Inc. (CV - Free Report) recently announced that it has submitted a 510(k) application to the FDA for approval to add an AI-based reading feature to its CapsoCam Plus capsule endoscopy system. The proposed AI feature is designed to improve the image review process, enhance diagnostic accuracy and improve workflow efficiency for clinicians. Upon FDA clearance, the company plans to commence selling the upgraded product in the United States.
Per management, FDA submission is an important step in CV’s goal to deliver a capsule endoscopy solution that uses advanced AI-based imaging to diagnose small intestine conditions. The company believes that the combination of advanced imaging, in-house AI models and fully cloud-based systems positions CapsoCam Plus as a next-generation solution for small bowel diagnostics and GI practices of all sizes.
CV Stock Trend Following the News
Shares of CapsoVision declined 7.7% since the announcement on Monday. Over the past six months, shares of the company have soared 205.4% compared with the industry’s 0.6% growth and the S&P 500’s 12.7% rise.
In the long run, FDA clearance and the addition of an AI-assisted reading tool to CapsoCam Plus enhance CapsoVision’s ability to address two major pain points in GI diagnostics — lengthy image review processes and variability in the detection and diagnosis of gastrointestinal diseases. This development supports wider adoption of AI-enabled medical imaging among gastroenterology practices and improves the company’s competitive positioning in the fast-developing field of AI-powered medical diagnostics.
CV currently has a market capitalization of $580.39 million.
Image Source: Zacks Investment Research
More on the AI-Assisted CapsoCam Plus
CapsoCam Plus AI feature is designed to visualize inside the small intestine to find medical problems in adults and children aged two years and older by capturing comprehensive panoramic images of the gastrointestinal tract. Its AI-assisted system is more advanced than competing products because it captures clearer images of the digestive tract to highlight areas that may need attention, saves time by reducing the chance of missing problems and overall offers an easier experience for both doctors and patients.
CapsoVision’s AI-assisted reading module leverages its in-house image dataset to identify clinically significant pathology, improve diagnostic reading accuracy while reducing clinician review burden. The growing collection of high-quality medical images helps train advanced AI models and discover new clinical insights, making CV’s AI-enabled diagnostic platform stand out from competitors.
CapsoVision’s fully cloud-based system prevents the need for on-site servers, lowers upfront costs, reduces downtime and removes IT maintenance requirements for GI practices by offering a diagnostic platform that is easier to use and more accurate. Together, an AI-upgraded and cloud-based deployment strengthens CapsoVision’s long-term growth strategy, positioning the company to benefit from growing capsule-based GI diagnostics.
Industry Prospects Favoring the Market
Going by data provided by Precedence Research, the capsule endoscopy market is valued at $479.13 million in 2025 and is expected to witness a CAGR of 7.95% through 2034. Factors like the rising adoption of minimally invasive diagnostics in gastrointestinal care, AI-enabled image interpretation, increasing use of capsule endoscopy in pediatric and geriatric populations and growing clinical trials validating capsule endoscopy for oncology screening are driving market growth.
Other News
In November 2025, CapsoVision announced that it had applied to the FDA for Breakthrough Device Designation to speed up the development of its CapsoCam UGI capsule. This non-invasive capsule endoscopy system is designed to detect early-stage pancreatic ductal adenocarcinoma, aiming to improve outcomes for one of the deadliest cancers worldwide.
The company is also working on its pipeline product, CapsoCam Colon, with advanced AI to allow non-invasive imaging of the colon and help detect polyps.
CapsoVision, Inc. Price
CapsoVision, Inc. price | CapsoVision, Inc. Quote
CV’s Zacks Rank & Key Picks
Currently, CV carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the broader medical space are Omnicell (OMCL - Free Report) , CareCloud and Schrodinger (SDGR - Free Report) .
Omnicell, sporting a Zacks Rank #1 (Strong Buy) at present, reported third-quarter 2025 adjusted earnings per share (EPS) of 51 cents, which surpassed the Zacks Consensus Estimate by 41.7%. Revenues of $311 million beat the Zacks Consensus Estimate by 5.6%. You can see the complete list of today’s Zacks #1 Rank stocks here.
OMCL has an estimated long-term earnings growth rate of 9.4% compared with the industry’s 27.9% rise. The company beat earnings estimates in the trailing four quarters, the average surprise being 38.65%.
CareCloud, currently carrying a Zacks Rank #2 (Buy), reported a third-quarter 2025 adjusted EPS of 10 cents, which surpassed the Zacks Consensus Estimate by 25%. Revenues of $31.1 million beat the Zacks Consensus Estimate by 8.3%.
CCLD has an estimated earnings recession rate of 45.3% for 2025 against the industry’s 20.1% growth. The company missed earnings estimates in the trailing four quarters, the average surprise being 2.88%.
Schrodinger, currently carrying a Zacks Rank #2, reported a third-quarter 2025 loss per share of 45 cents, narrower than the Zacks Consensus Estimate by 40%. Revenues of $54.3 million beat the Zacks Consensus Estimate by 8.7%.
SDGR has an estimated long-term earnings growth rate of 37.8% compared with the industry’s 27.9% growth. The company’s earnings have missed estimates in the trailing four quarters, the average surprise being 0.93%.