CapsoVision gets FDA clearance for capsule-video AI
AI Highlights had launched internationally earlier this year, including in the European Union under the Medical Device Regulation.
Rhea-AI Filing Summary
CapsoVision, Inc. (CV) announced that its AI Highlights reading tool for the CapsoCam Plus system received U.S. Food and Drug Administration clearance on September 25, 2026. The tool is designed to support physicians reviewing small bowel capsule endoscopy studies from adult and pediatric patients over two years of age when the study was performed due to suspected small bowel bleeding.
AI Highlights analyzes capsule video frames, marks images containing suspected abnormal lesions, and prioritizes them for physician review. It is designed to reduce the time taken to review capsule endoscopy images. The feature integrates with CapsoView software and supports connected CapsoCloud workflows, depending on workflow configuration. It is intended for trained healthcare professionals and is not intended to replace gastroenterologists’ diagnostic interpretation or, where applicable, histopathological sampling.
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8-K Event Classification
2 items: 8.01, 9.01
2 items
Item 8.01
Other Events
Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, or exhibit attachments filed with this report.
Key Figures
FDA clearance date: September 25, 2026
Company announcement date: September 28, 2026
Patient age: Over two years of age
3 metrics
FDA clearance date
September 25, 2026
AI Highlights for the CapsoCam Plus system
Company announcement date
September 28, 2026
Announcement of AI Highlights clearance
Patient age
Over two years of age
Patients in the described small bowel capsule endoscopy studies
Key Terms
AI-assisted reading tool, small bowel capsule endoscopy, histopathological sampling, Medical Device Regulation
4 terms
AI-assisted reading tool technical
"AI-assisted reading tool for the CapsoCam Plus system"
small bowel capsule endoscopy medical
"small bowel capsule endoscopy studies"
histopathological sampling medical
"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.
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.
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What did the FDA clear for CV?
The FDA cleared AI Highlights for the CapsoCam Plus system on September 25, 2026. The tool is designed to mark images containing suspected abnormal lesions and prioritize them for physician review in studies performed due to suspected small bowel bleeding.
Does CV’s AI Highlights replace a gastroenterologist’s interpretation?
No. AI Highlights is intended for trained healthcare professionals and is not intended to replace gastroenterologists’ diagnostic interpretation or, where applicable, histopathological sampling.
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
_________________________
FORM 8-K
_________________________
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): September 25, 2026
_________________________
(Exact name of registrant as specified in its charter)
_________________________
| (State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification Number) | ||||||||||||
| (Address of Principal Executive Offices) | (Zip Code) | |||||||
Registrant’s telephone number, including area code: (408) -624-1488
n/a
(Former Name or Former Address, if Changed Since Last Report)
_________________________
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |||||
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |||||
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |||||
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) | |||||
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol | Name of each exchange on which registered | ||||||||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 8.01. Other Events.
On September 28, 2026, the Company announced that AI Highlights™, its AI-assisted reading feature for the CapsoCam Plus® system, received clearance from the U.S. Food and Drug Administration on September 25, 2026.
The press release is filed herewith as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d)The following exhibits are being filed herewith:
| Exhibit No. | Description | |||||||
| 99.1 | Press Release issued on September 28, 2026. | |||||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |||||||
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| CAPSOVISION, INC. | ||||||||
| Date: September 28, 2026 | By: | /s/ Kang-Huai (Johnny) Wang | ||||||
| Name: | Kang-Huai (Johnny) Wang | |||||||
| Title | President and Chief Executive Officer | |||||||
Exhibit 99.1
CapsoVision Announces FDA Clearance of AI Highlights for CapsoCam Plus®
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., September 28, 2026 -- 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
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