[8-K] CapsoVision, Inc Reports Material Event

Rhea-AI Filing Summary

CapsoVision, Inc. reported that it issued a press release announcing a 510(k) FDA application for Breakthrough Device Designation for its Pancreatic Cancer Screening Capsule. The disclosure was furnished under Item 8.01 and includes the press release as Exhibit 99.1 dated November 10, 2025.

This notice signals a regulatory step only; it does not reflect FDA clearance or authorization. The company did not disclose financial terms or operational changes in this update.

Insights

Regulatory Affairs Analyst

Administrative step: company announced an application, not an approval.

CapsoVision stated it issued a press release about a 510(k) FDA application seeking Breakthrough Device Designation for a Pancreatic Cancer Screening Capsule. This indicates pursuit of an expedited review pathway if granted, but no regulatory decision is included here.

The filing furnishes the press release under Item 8.01 with Exhibit 99.1 and makes no claims of clearance or authorization. No proceeds, costs, or commercialization timelines are provided in the excerpt.

FALSE000137832500013783252025-11-102025-11-10

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): November 10, 2025

_________________________

CapsoVision, Inc.

(Exact name of registrant as specified in its charter)

_________________________

Delaware

001-42705

20-3369494

(State or other jurisdiction of incorporation)

(Commission File Number)

(IRS Employer Identification Number)

18805 Cox Avenue, Suite 250 Saratoga, California						95070
(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:

o			Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o			Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o			Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o			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

common stock, $0.001 par value per share

CV

The Nasdaq Stock Market LLC

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 November 10, 2025, the Company issued a press release announcing the 510(k) FDA application for Breakthrough Device Designation for Pancreatic Cancer Screening Capsule.

Copies of the press releases are attached hereto as Exhibit 99.1. The information provided under this Item 8.01, including the accompanying press releases, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section. This information will not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except to the extent that the registrant specifically incorporates it 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 November 10, 2025.
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: November 10, 2025			By:			/s/ Kang-Huai (Johnny) Wang
			Name:			Kang-Huai (Johnny) Wang
			Title			President and Chief Executive Officer