BrainsWay gets FDA clearance for Deep TMS in adolescent MDD

BrainsWay Ltd. furnished a Form 6-K reporting that it received FDA clearance for its Deep TMS therapy as an adjunct treatment for major depressive disorder (MDD) in adolescents aged 15 to 21.

Rhea-AI Filing Summary

BrainsWay Ltd. furnished a Form 6-K reporting that it received FDA clearance for its Deep TMS therapy as an adjunct treatment for major depressive disorder (MDD) in adolescents aged 15 to 21. The update is provided as an exhibit to the report. The company also notes that this Form 6-K is incorporated by reference into its existing U.S. registration statements on Form S-8 and Form F-3.

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Accepted by SEC EDGAR 11/13/2025 - 06:00 AM EST Learn about SEC filing dates

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

Form 6-K

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the month of November 2025

Commission File Number: 001-35165

BRAINSWAY LTD.
(Translation of registrant's name into English)

16 Hartum Street RAD Tower, 14th Floor
Har HaHotzvim
Jerusalem, 9777516, Israel
(+972-2) 582-4030
 (Address and telephone number of Registrant’s principal executive office)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F [ X ]      Form 40-F [   ]

This Form 6-K is incorporated by reference into the Company's Registration Statement on Form S-8 filed with the Securities and Exchange Commission on April 22, 2019 (Registration No. 333- 230979) and the Company's Registration Statements on Form F-3 filed with the Securities and Exchange Commission on July 22, 2024 (Registration No. 333-280934) and on April 22, 2025 (Registration No. 333-286672).

EXHIBIT INDEX

Exhibit		Title
99.1		BrainsWay Receives FDA Clearance of Deep TMS™ as Adjunct Therapy for Major Depressive Disorder (MDD) in Adolescents Aged 15 to 21

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, thereunto duly authorized.

		BRAINSWAY LTD.
		(Registrant)
Date: November 13, 2025		/s/ Hadar Levy
		Hadar Levy
		Chief Executive Officer