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CBLL · Current Report (Form 8-K) · Filed January 5, 2026

Ceribell Inc — Current Report (Form 8-K)

Form
8-K
Filed
January 5, 2026
Period
Jan 5, 2026
Ticker
CBLL
Accession
0001193125-26-001800
Ceribell Inc on Boardroom AlphaView on SEC EDGAR
Boardroom Alpha · Filing insights

FDA grants Breakthrough Device Designation to Ceribell's LVO stroke detection solution.

About Ceribell Inc
Market cap
$664M
1Y TSR
+3.5%
Board grade
C-
Sector
Healthcare
CEO
Xingjuan Chao
Last annual meeting: Jun 2, 2026 · View full Ceribell Inc profile →
8-K

 

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): January 05, 2026

 

 

CeriBell, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-42364

47-1785452

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

360 N. Pastoria Avenue

 

Sunnyvale, California

 

94085

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: 800 436-0826

 

 

(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(s)

 


Name of each exchange on which registered

Common stock, $0.001 par value per share

 

CBLL

 

Nasdaq Global Select Market

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 January 5, 2026, CeriBell, Inc. (“Ceribell”) issued a press release announcing that the U.S. Food and Drug Administration (“FDA”) granted Breakthrough Device Designation for Ceribell’s Large Vessel Occlusion (LVO) stroke detection and monitoring solution.

 

A copy of the press release is attached as Exhibit 99.1 and is incorporated herein by reference.

 

 

Item 9.01

Financial Statements and Exhibits.

 

Exhibit No.

Description

99.1

Press Release dated January 5, 2026.

104

Cover Page Interactive Data File, formatted in Inline XBRL.

 

 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

CERIBELL, INC.

 

 

 

 

Date:

January 5, 2026

By:

/s/ Scott Blumberg

 

 

 

Scott Blumberg
Chief Financial Officer

 

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Reference

Frequently asked questions

When did Ceribell Inc file this 8-K?
Ceribell Inc (CBLL) filed this Current Report (Form 8-K) with the SEC on January 5, 2026. The accession number assigned by EDGAR is 0001193125-26-001800.
What does an 8-K disclose?
Form 8-K is the SEC's current-report form, used to disclose material events between periodic reports (10-K / 10-Q). Triggers include CEO/CFO departures, acquisitions, bankruptcies, earnings releases, auditor changes, changes in fiscal year, and amendments to corporate governance. Each 8-K is keyed to one or more Item numbers (1.01 through 9.01).
What is the key takeaway from this filing?
FDA grants Breakthrough Device Designation to Ceribell's LVO stroke detection solution. This is Boardroom Alpha's one-line summary of the current report; see the full filing text above for the formal disclosure.
What Item codes does an 8-K cover?
An 8-K's Item codes (1.01 through 9.01) specify what kind of event is being disclosed — e.g. Item 1.01 for entering a material agreement, Item 5.02 for departure/election of directors and executive officers, Item 8.01 for other events. The Item codes for this 8-K appear in the filing text above.
Where can I find Ceribell Inc's prior current reports on EDGAR?
The SEC EDGAR browser lists every 8-K Ceribell Inc has filed under CIK 1861107, sortable by date. Use the "View on SEC EDGAR" link in the page header, or browse directly via https://www.sec.gov/cgi-bin/browse-edgar.
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