CapsoVision Announces FDA Clearance of AI Highlights for CapsoCam Plus®

AI Highlights launched internationally earlier in 2026, including in the European Union under the Medical Device Regulation.

Rhea-AI Summary

CapsoVision (CV) received FDA clearance on September 25, 2026, for AI Highlights, an AI-assisted reading tool for CapsoCam Plus. The tool is designed to reduce image-review time for small bowel capsule endoscopy studies performed because of suspected bleeding in adults and children over two years old. It identifies and marks images with suspected abnormal lesions, then highlights them for physician review.

AI Highlights analyzes CapsoCam Plus frames during video processing and works with CapsoView review software and connected CapsoCloud workflows, depending on configuration. It is intended for trained healthcare professionals and does not replace gastroenterologists’ diagnostic interpretation or, where applicable, histopathological sampling.

Positive

• FDA clearance for AI Highlights received September 25, 2026

Negative

• None.

Market Context

On Aug. 3, the international AI Highlights launch was followed by a 3.21% decline; that earlier resp...

Analysis

On Aug. 3, the international AI Highlights launch was followed by a 3.21% decline; that earlier response provides same-product context for this separate U.S. clearance milestone.

Key Figures

FDA clearance date: September 25, 2026 Minimum patient age: Over 2 years

FDA clearance date

September 25, 2026

AI Highlights for CapsoCam Plus

Minimum patient age

Over 2 years

Intended-use population for small bowel capsule endoscopy studies

Historical Context

1 past event · Latest: Aug 03

1 event

1. Aug 03

   AI launch

   24h Move

   -3.2%

   International AI Highlights launch preceded U.S. FDA clearance for the same CapsoCam Plus tool.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

fda clearance, capsule endoscopy, medical device regulation, histopathological sampling

4 terms

fda clearance regulatory

"received clearance from the U.S. Food and Drug Administration (FDA)"

FDA clearance is the U.S. Food and Drug Administration’s official permission to market certain medical devices or diagnostic tests after reviewing evidence that they are as safe and effective as similar products already on the market. For investors, it’s like a product passing a required safety inspection — it reduces regulatory uncertainty, speeds commercial rollout, and can directly affect sales prospects, valuation, and partnership opportunities.

capsule endoscopy medical

"small bowel capsule endoscopy studies collected from adult and pediatric patients"

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.

medical device regulation regulatory

"in the European Union under the Medical Device Regulation"

Rules and processes governments require for making, testing, approving, and monitoring medical devices so they are safe and work as intended. Think of it like a building code and inspection process for devices: meeting these rules can be costly and slow but opens markets and reduces the risk of recalls and legal trouble, while failure to comply can cut revenue, delay product launches, or cause fines—issues investors watch closely.

histopathological sampling medical

"or, where applicable, histopathological sampling"

Removal and preparation of small pieces of tissue so a pathologist can examine them under a microscope to identify disease, measure tumor features, or confirm how tissue responds to treatment. Think of it like taking close-up samples of a damaged area to see its structure and cause; the results guide medical diagnoses, trial endpoints, and regulatory decisions that can affect a therapy’s development or a diagnostic product’s credibility.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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AI-assisted reading tool designed to aid physician review of small bowel capsule endoscopy studies performed due to suspected bleeding using the CapsoCam Plus® system

SARATOGA, Calif., Sept. 28, 2026 (GLOBE NEWSWIRE) -- CapsoVision, Inc. (NASDAQ: CV), a commercial-stage medical technology company developing advanced imaging and AI-enabled capsule endoscopy solutions, today announced that AI Highlights™, its AI-assisted reading tool for the CapsoCam Plus system, received clearance from the U.S. Food and Drug Administration (FDA) on September 25, 2026.

AI Highlights is designed to support physicians in the review of small bowel capsule endoscopy studies collected from adult and pediatric patients (over two years of age) in whom the study was performed due to suspected small bowel bleeding, specifically to reduce the time taken to review capsule endoscopy images. It does so through recognizing and marking images containing suspected abnormal lesions, which are highlighted and prioritized for physician review. The feature integrates with CapsoView®, CapsoVision’s video processing and review software, and supports workflows connected to the Company’s CapsoCloud® platform. During video processing, the AI algorithm analyzes frames captured by the CapsoCam Plus capsule. AI-processed studies can then support physician review within connected CapsoView or CapsoCloud workflows, depending on workflow configuration.

“FDA clearance of AI Highlights represents an important milestone in the continued evolution of the CapsoVision platform and our commitment to bringing integrated, AI-assisted technologies to physicians in the United States,” said Johnny Wang, President and Chief Executive Officer of CapsoVision. “Following the international launch of AI Highlights earlier this year, including in the European Union under the Medical Device Regulation, we are pleased to reach this important regulatory milestone in the United States. We believe AI-assisted review tools may help support physician efficiency and may help improve reading performance as capsule endoscopy adoption continues to expand.”

Integrated within the CapsoVision ecosystem, AI Highlights works across the connected CapsoCloud workflow to support capsule endoscopy review without the need for a separate AI platform. Where and when available, CapsoCloud enables organizations to securely access AI-processed videos for remote physician review, collaboration, and case management.

The AI Highlights reading tool that was reviewed and cleared by the FDA represents a part of comprehensive updates to the CapsoView and CapsoCloud software. AI Highlights is intended to be used by trained healthcare professionals and is not intended to replace gastroenterologists’ diagnostic interpretation or, where applicable, histopathological sampling. Please refer to the product’s Instructions for Use for complete information regarding indications, contraindications, warnings, precautions, and limitations.

About CapsoVision

CapsoVision is a commercial-stage medical technology company focused on developing advanced imaging and AI-enabled solutions to transform the detection and screening 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 review. 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,” “anticipate(s),” “intend(s),” “plan(s),” “believe(s),” “potential,” “will,” “should,” “could,” “would,” “may,” “continue,” “remain,” “target(ed)”, "expand", or "improve" 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 and financial position, including the Company’s expectations regarding the Company’s product and clinical development efforts, the timing and receipt of regulatory submissions and approvals, the Company’s plans, strategies and timing for its pipeline development the Company’s expectations regarding the potential benefits of AI-assisted review tools to support physician efficiency and reading performance, the Company’s expectations regarding continued expansion of capsule endoscopy adoption, 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 (including competition in the capsule endoscopy market), the Company’s financial condition and the availability of cash and financing, and the success of the Company’s product and clinical development efforts, 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 most recent Form 10-K and 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

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What is CapsoVision’s AI Highlights cleared to do?

AI Highlights is cleared to support physician review of CapsoCam Plus small bowel capsule endoscopy studies performed because of suspected bleeding in adults and children over two years old. It marks images containing suspected abnormal lesions and prioritizes them for review.

Can clinicians review CapsoVision AI Highlights-processed videos remotely?

CapsoCloud, where and when available, lets organizations access AI-processed videos for remote physician review, collaboration and case management. Whether a study is reviewed through a connected CapsoView or CapsoCloud workflow depends on the workflow configuration.