BrainsWay (BWAY) notes FDA approval of Neurolief’s Proliv Rx for MDD

Rhea-AI Filing Summary

BrainsWay Ltd. submitted a current report for January 2026 that centers on a regulatory milestone related to depression treatment. The report attaches a press release titled “BrainsWay Announces FDA Approval of Neurolief’s Proliv™Rx Neuromodulation System for Major Depressive Disorder (MDD).” This indicates that the U.S. Food and Drug Administration has approved Neurolief’s Proliv™Rx neuromodulation system specifically for treating major depressive disorder. The filing also notes that this report is incorporated by reference into BrainsWay’s existing Form S-8 and Form F-3 registration statements.

Positive

• Regulatory milestone disclosed: The report highlights FDA approval of Neurolief’s Proliv™Rx neuromodulation system for treating major depressive disorder (MDD), a significant step for any medical device in this area.

Negative

• None.

Insights

Medical device and regulatory analyst

BrainsWay highlights FDA approval of a neuromodulation system for major depressive disorder.

The report from BrainsWay Ltd. centers on FDA approval of Neurolief’s Proliv™Rx neuromodulation system for treating major depressive disorder (MDD), as reflected in the attached press release title. FDA approval is a key regulatory hurdle for any medical device aimed at a serious mental health condition, signaling that the product met U.S. safety and effectiveness standards for its indicated use.

While the excerpt does not describe the commercial terms or BrainsWay’s exact role, it shows the company formally highlighting this approval to U.S. investors via a current report. The document also incorporates this report into existing Form S-8 and Form F-3 registration statements, which helps align ongoing securities offerings with this regulatory development.

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 January 2026

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 Announces FDA Approval of Neurolief’s Proliv™Rx Neuromodulation System for Major Depressive Disorder (MDD)

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: January 12, 2026		/s/ Hadar Levy
		Hadar Levy
		Chief Executive Officer