CapsoVision Announces 510(k) Submission for the Addition of AI-Assisted Reading Module in CapsoCam Plus®

Rhea-AI Summary

CapsoVision (NASDAQ: CV) submitted a 510(k) to the U.S. Food and Drug Administration on Dec. 29, 2025 for an AI-assisted reading module for its CapsoCam Plus capsule endoscopy system.

The module is intended to improve detection of clinically significant small-bowel pathology and reduce clinician review time. The company said it plans to begin U.S. commercialization after FDA clearance. CapsoCam Plus is indicated for visualization of the small bowel mucosa in adults and children aged two years and older.

CapsoVision highlighted in-house AI capabilities, a growing image data set for model training, and a fully cloud-based architecture intended to remove on-site servers and reduce IT maintenance.

News Market Reaction

-10.99%

18 alerts

-10.99% News Effect

+13.7% Peak Tracked

-7.5% Trough Tracked

-$80M Valuation Impact

$644M Market Cap

0.5x Rel. Volume

On the day this news was published, CV declined 10.99%, reflecting a significant negative market reaction. Argus tracked a peak move of +13.7% during that session. Argus tracked a trough of -7.5% from its starting point during tracking. Our momentum scanner triggered 18 alerts that day, indicating notable trading interest and price volatility. This price movement removed approximately $80M from the company's valuation, bringing the market cap to $644M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Patient age indication: 2 years and older

1 metrics

Patient age indication 2 years and older CapsoCam Plus small bowel visualization indication

Market Reality Check

Price: $4.83 Vol: Volume 58,792 is below th...

low vol

$4.83 Last Close

Volume Volume 58,792 is below the 20-day average of 397,800, indicating muted trading interest pre‑announcement. low

Technical Shares at $13.01 were trading above the 200-day MA of $5.43 and 15.35% below the 52-week high of $15.37.

Peers on Argus

Before the AI 510(k) news, CV was down 6.27% while key peers showed mixed moves:...

Before the AI 510(k) news, CV was down 6.27% while key peers showed mixed moves: ARAY -3.53%, SGHT -2.67%, CVRX -3.11%, MXCT +0.62%, and BSGM +39.91%, pointing to a stock-specific setup rather than a coordinated sector move.

Historical Context

5 past events · Latest: Nov 20 (Neutral)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Nov 20	Investor conference	Neutral	+0.0%	Management attendance at Benchmark one-on-one investor conference.
Nov 13	Earnings update	Positive	+2.4%	Q3 2025 results with revenue and gross profit growth and IPO cash.
Nov 10	Regulatory submission	Positive	+4.4%	FDA Breakthrough Device Designation application for pancreatic screening capsule.
Nov 03	Leadership change	Neutral	-2.0%	Appointment of David Garcia as Senior Vice President of Finance.
Oct 30	Earnings scheduling	Neutral	+3.8%	Announcement of date and call details for Q3 2025 results release.

Pattern Detected

Recent news and earnings have generally seen modest positive price reactions, particularly around regulatory and clinical updates, with limited response to conference participation and a small decline on a finance leadership change.

Recent Company History

Over the last few months, CapsoVision has reported growing Q3 revenue of $3.5 million with higher gross profit, advanced its pipeline with a Breakthrough Device Designation submission for a pancreatic cancer capsule, and added a new SVP of Finance. News about conferences and earnings dates had small or neutral price impacts. Against this backdrop, today’s AI-assisted reading 510(k) submission fits a pattern of ongoing product and regulatory progress in capsule endoscopy.

Market Pulse Summary

The stock dropped -11.0% in the session following this news. A negative reaction despite an AI-focus...

Analysis

The stock dropped -11.0% in the session following this news. A negative reaction despite an AI-focused 510(k) submission would contrast with earlier modest gains on regulatory updates. The market may already have priced in some innovation after prior news, while regulatory timelines and ongoing net losses highlighted in recent filings could amplify caution. Past events showed mostly small positive moves, so a pronounced decline from $13.01 would represent a more skeptical stance toward execution and funding risk.

Key Terms

510(k), Food and Drug Administration, capsule endoscopy, mucosa, +4 more

8 terms

510(k) regulatory

"announced submission of its 510(k) application to the Food and Drug Administration"

A 510(k) is a U.S. regulatory submission that a medical device maker uses to show a new device is as safe and effective as an already-approved device, allowing the regulator to clear it for sale rather than requiring the longer, more stringent approval process. For investors, a cleared 510(k) usually means lower regulatory risk and a faster path to market, which can speed revenue generation and reduce uncertainty—similar to proving a new appliance works like a trusted existing model.

Food and Drug Administration regulatory

"510(k) application to the Food and Drug Administration (FDA)"

A government agency that reviews and regulates medicines, medical devices, food safety, and related products to ensure they are safe and effective for public use. Investors watch its actions like a referee’s calls: approvals, warnings, inspections or recalls can directly affect a product’s ability to reach the market, a company’s sales and costs, and overall business risk and valuation.

capsule endoscopy medical

"AI-enabled capsule endoscopy solutions, today announced submission"

A capsule endoscopy is a diagnostic procedure in which a person swallows a pill-sized device that contains a tiny camera, light and transmitter; it wirelessly records images as it travels through the digestive tract. Investors care because the technology can replace or complement traditional, more invasive tests — affecting demand, device sales, recurring consumable revenue, regulatory approval paths and insurance coverage, all of which influence a medical company’s growth and profitability.

mucosa medical

"intended for visualization of the small bowel mucosa to detect abnormalities"

The mucosa is the soft, moist lining that coats body passages and cavities such as the inside of the mouth, nose, gut and lungs; think of it like a protective wallpaper that also secretes mucus to trap particles and help tissues heal. For investors, mucosal health matters because many drugs, vaccines and diagnostic tests target or must pass through these linings, so their condition affects treatment effectiveness, safety, regulatory approval and market potential.

GI tract medical

"images of the GI tract and the clinical workflow and patient experience"

The GI tract is the body’s continuous tube—from mouth to stomach, intestines and anus—that breaks down food, absorbs nutrients and expels waste. Think of it as the body’s plumbing and processing line: problems or treatments affecting this system can change how drugs are absorbed, create safety concerns, drive demand for treatments or devices, and influence regulatory approval and commercial prospects, making it important to investors in healthcare and related sectors.

cloud-based architecture technical

"Combined with our fully cloud-based architecture—which eliminates the need"

Cloud-based architecture is a way of building and running software so its components live on remote servers accessed over the internet instead of on local computers. For investors it matters because this design lets companies scale computing power up or down like renting space in a warehouse, often lowering upfront costs, speeding product launches, and improving resilience, while shifting some risks to ongoing operating expenses and outside providers.

AI-assisted technical

"its proprietary AI-assisted module for CapsoCam Plus"

AI-assisted describes products, services or processes where software powered by artificial intelligence helps humans perform tasks by analyzing data, suggesting decisions or automating routine steps while a person keeps final control. For investors, AI-assistance matters because it can boost speed, lower costs and scale operations like a high-powered calculator or GPS for complex work, but it also introduces risks from errors, bias and regulatory scrutiny that can affect performance and liability.

panoramic imaging medical

"The non-invasive, swallowed capsule provides panoramic imaging to visualize"

A panoramic imaging system produces a single wide-angle picture that shows a broad area of anatomy—commonly the entire jaw and teeth in dental care—by stitching together data from a moving X-ray or sensor. Investors care because it replaces multiple small images with one faster, lower-cost exam that can speed diagnosis, increase clinic throughput, and drive sales of imaging equipment and consumables, affecting revenue and adoption trends.

AI-generated analysis. Not financial advice.

Company Preparing to Commence Commercialization Following U.S. FDA 510(k) Clearance

SARATOGA, Calif., Dec. 29, 2025 (GLOBE NEWSWIRE) -- CapsoVision, Inc. (NASDAQ: CV), a commercial-stage medical technology company developing advanced imaging and AI-enabled capsule endoscopy solutions, today announced submission of its 510(k) application to the Food and Drug Administration (FDA) for its proprietary AI-assisted module for CapsoCam Plus®. The addition of this reading tool will improve the detection of clinically significant pathology, as well as reduce clinician review time. The Company intends for U.S. commercialization activities to commence after the FDA clearance.

CapsoVision’s CapsoCam Plus capsule endoscopy system is intended for visualization of the small bowel mucosa to detect abnormalities of the small bowel in adults and children aged two years and older. The Company believes that it is a more advanced capsule endoscopy solution compared to competitor systems, both in how it captures and presents images of the GI tract and the clinical workflow and patient experience that it enables.

“This submission marks an important milestone in our commitment to customers and patients towards advancing a best-in-class solution that integrates advanced imaging with AI-powered interpretation for small bowel diagnostics,” said Johnny Wang, President and Chief Executive Officer. “We believe we are the only capsule endoscopy company with in-house AI core competency, and the scale and quality of our growing image data trove create a powerful foundation for training AI models and uncovering new clinical insights that will set our platform apart from competitive options. Combined with our fully cloud-based architecture—which eliminates the need for on-site servers, reduces cost and downtime, and removes the burden of IT maintenance—we are delivering an AI-enabled diagnostic platform designed to bring efficiency, accuracy, and accessibility to GI practices of all sizes.”

About CapsoVision
CapsoVision 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’s next pipeline product, CapsoCam Colon™ with enhanced AI, is designed to enable non-invasive colon imaging and polyp detection. With a proprietary platform targeted to expand across multiple GI indications, including esophageal and pancreatic disorders, CapsoVision is advancing a new era in capsule-based diagnostics. For more information on CapsoVision, please visit www.capsovision.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In this context, forward-looking statements mean statements related to future events, which may impact our expected future business and financial performance, and often contain words such as “expected”, “anticipates”, “intends”, “plans”, “believes”, “potential”, “will”, “should”, “could”, “would” or “may” and other words of similar meaning. Examples of these forward-looking statements include, but are not limited to, statements concerning possible or assumed future results of operations, including the timing and receipt of regulatory approvals, the Company’s plans, strategies and timing for its pipeline development, and the success of the Company’s plans and strategies. These forward-looking statements are based on the Company’s current expectations and inherently involve significant risks and uncertainties, including those beyond the Company’s control. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, market conditions and the failure to receive regulatory clearance. These and other risks and uncertainties are described more fully in the Company’s filings with the Securities and Exchange Commission (“SEC”), including the “Risk Factors” section of the Company’s prospectus filed on July 3, 2025 with the SEC, as part of the Company’s Registration Statement on Form S-1 (File No. 333-287148), and the Company’s most recent Form 10-Q. Forward-looking statements speak only as of the date of this press release, and the Company undertakes no obligation to update or revise these statements, except as required by law.

Investor Relations Contact
Leigh Salvo
New Street Investor Relations
Investors@CapsoVision.com

Media Contact
Leslie Strickler and Paul Spicer
Être Communications
leslies@etrecommunications.com | (804) 240-0807
pauls@etrecommunications.com | (804) 503-9231

FAQ

What did CapsoVision (CV) file with the FDA on December 29, 2025?

CapsoVision filed a 510(k) submission for an AI-assisted reading module for CapsoCam Plus.

How could the AI-assisted module affect CapsoCam Plus performance for CV shareholders?

The company says the module is designed to improve detection of clinically significant pathology and reduce clinician review time.

When does CapsoVision (CV) plan U.S. commercialization of the AI module?

CapsoVision intends to commence U.S. commercialization after FDA 510(k) clearance.

What patient ages is CapsoCam Plus indicated for in the CapsoVision (CV) announcement?

CapsoCam Plus is intended for visualization of the small bowel mucosa in adults and children aged two years and older.

What competitive advantages did CapsoVision (CV) highlight for its AI offering?

CapsoVision cited in-house AI expertise, a growing image data trove for model training, and a fully cloud-based architecture that removes on-site servers.

Does the 510(k) submission mean the AI module is cleared for sale now?

No; the submission initiates FDA review—commercialization is planned after 510(k) clearance, not before.