[6-K] EDAP TMS SA Current Report (Foreign Issuer)

Rhea-AI Filing Summary

EDAP TMS S.A. (EDAP) reported that the U.S. Food and Drug Administration has granted 510(k) clearance for new ultrasound imaging and workflow enhancements to its Focal One High Intensity Focused Ultrasound (HIFU) system used in robotic focal therapy for prostate cancer. The clearance covers advanced ultrasound imaging, streamlined treatment planning, and an optimized user interface for the recently launched Focal One i platform.

EDAP states that the next generation ultrasound imaging engine provides real-time visualization and supports the potential development of AI-driven algorithms to assist surgeons with tissue ablation visualization and treatment evaluation. Management describes this as an important technical milestone that further strengthens Focal One’s product roadmap and reinforces its global leadership positioning in focal therapy.

Positive

• FDA 510(k) clearance obtained for new ultrasound imaging and workflow enhancements to the Focal One HIFU system, adding cleared functionality to an existing prostate cancer focal therapy platform.
• Next generation imaging engine provides real-time visualization and supports the potential development of AI-driven algorithms for tissue ablation visualization and treatment evaluation.
• Management highlights this as an important technical milestone that strengthens the Focal One product roadmap and reinforces EDAP’s stated global leadership positioning in focal therapy.

Negative

• None.

Insights

Medical device and regulatory analyst

FDA 510(k) clearance enhances EDAP's Focal One i imaging and workflow.

EDAP TMS received FDA 510(k) clearance for new ultrasound imaging and workflow enhancements to its Focal One HIFU platform for prostate cancer focal therapy. The clearance covers advanced ultrasound imaging, streamlined treatment planning, and an optimized user interface for the Focal One i system launched earlier this year, deepening the feature set of an already commercial platform.

The company notes that the next generation imaging engine enables real-time visualization and supports the potential development of AI-driven algorithms to help surgeons with tissue ablation visualization and treatment evaluation. This ties regulatory clearance directly to product functionality rather than a new indication, staying within the existing prostate cancer focal therapy space.

Management characterizes the clearance as an important technical milestone that strengthens Focal One’s product roadmap and reinforces its global leadership in focal therapy. While no adoption or revenue figures are given, this type of enhancement can influence surgeon experience and competitive positioning, with future disclosures in company filings likely to provide more detail on market impact.

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

November 20, 2025

Commission File Number: 0-29374

EDAP TMS S.A.
Parc Activite La Poudrette Lamartine
4/6 Rue du Dauphine
69120 Vaulx-en-Velin - France

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 [  ]

SIGNATURES

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

Date: November 20, 2025

EDAP TMS S.A.

/s/ SANKET SHAH
SANKET SHAH
GENERAL COUNSEL

EDAP Receives FDA 510(k) Clearance for Latest Evolution of Focal One Robotic HIFU

AUSTIN, Texas, November 20, 2025 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for new ultrasound imaging and workflow enhancements to the Focal One High Intensity Focused Ultrasound (HIFU) system, further strengthening the company’s market leadership in robotic focal therapy for prostate cancer.

The 510(k) clearance introduces advanced ultrasound imaging, streamlined treatment planning, and an optimized user-interface to the Focal One i launched earlier this year. The next generation ultrasound imaging engine provides real-time visualization and supports the potential development of AI-driven algorithms designed to assist surgeons with tissue ablation visualization and treatment evaluation.

“We are proud to receive this new FDA clearance, which further enhances the capabilities of the new Focal One i and represents another important technical milestone in Focal One’s product roadmap,” said Ryan Rhodes, Chief Executive Officer of EDAP TMS. “This achievement demonstrates our team’s continued commitment to innovation and reinforces Focal One’s global leadership in focal therapy.”

About EDAP TMS SA

A recognized leader in robotic energy-based therapies, EDAP TMS develops, manufactures, promotes and distributes worldwide minimally invasive medical devices for various conditions using ultrasound technology. By combining the latest technologies in imaging, robotics and precise non-invasive energy delivery, EDAP introduced the Focal One^® in Europe and in the U.S. as the leading prostate focal therapy controlled by urologists with the potential to expand to multiple indications beyond prostate cancer. For more information on the Company, please visit https://focalone.com/

Forward-Looking Statements

In addition to historical information, this press release contains forward-looking statements within the meaning of applicable federal securities laws, including Section 27A of the U.S. Securities Act of 1933 (the “Securities Act”) or Section 21E of the U.S. Securities Exchange Act of 1934, which may be identified by words such as “believe,” “can,” “contemplate,” “could,” “plan,” “intend,” “is designed to,” “may,” “might,” “potential,” “objective,” “target,” “project,” “predict,” “forecast,” “ambition,” “guideline,” “should,” “will,” “estimate,” “expect” and “anticipate,” or the negative of these and similar expressions, which reflect our views about future events and financial performance. Such statements are based on management's current expectations and are subject to a number of risks and uncertainties, including matters not yet known to us or not currently considered material by us, and there can be no assurance that anticipated events will occur or that the objectives set out will actually be achieved. Important factors that could cause actual results to differ materially from the results anticipated in the forward-looking statements include, among others, the clinical status and market acceptance of our HIFU devices and the continued market potential for our lithotripsy and distribution divisions, as well as risks associated with the current worldwide inflationary environment, the uncertain worldwide economic, political and financial environment, geopolitical instability, climate change and pandemics like the COVID 19 pandemic, or other public health crises, and their related impact on our business operations, including their impacts across our businesses or demand for our devices and services. Other factors that may cause such a difference may also include, but are not limited to, those described in the Company's filings with the Securities and Exchange Commission and in particular, in the sections "Cautionary Statement on Forward-Looking Information" and "Risk Factors" in the Company's Annual Report on Form 20-F.

Forward-looking statements speak only as of the date they are made. Other than required by law, we do not undertake any obligation to update them in light of new information or future developments. These forward-looking statements are based upon information, assumptions and estimates available to us as of the date of this press release, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete.

Investor Contacts

Investor Relations

EDAP TMS SA

investor.relations@focalone.com

John Fraunces

LifeSci Advisors, LLC

(917) 355-2395

jfraunces@lifesciadvisors.com

FAQ

What did EDAP TMS S.A. (EDAP) announce in this Form 6-K?

EDAP TMS S.A. announced that the U.S. Food and Drug Administration granted 510(k) clearance for new ultrasound imaging and workflow enhancements to its Focal One High Intensity Focused Ultrasound (HIFU) system used in robotic focal therapy for prostate cancer.

Which EDAP product is affected by the new FDA 510(k) clearance?

The clearance applies to Focal One, specifically the Focal One i HIFU system that was launched earlier in the year, adding advanced ultrasound imaging, streamlined treatment planning, and an optimized user interface.

How could the Focal One i enhancements benefit prostate cancer focal therapy?

The next generation ultrasound imaging engine provides real-time visualization and supports the potential development of AI-driven algorithms designed to assist surgeons with tissue ablation visualization and treatment evaluation in prostate cancer focal therapy procedures.

How does EDAP describe the strategic importance of this clearance?

EDAP’s Chief Executive Officer calls the new FDA clearance an important technical milestone that further enhances Focal One i’s capabilities and reinforces the system’s global leadership position in focal therapy.

Does this announcement change EDAP’s approved indications for Focal One?

The announcement focuses on ultrasound imaging and workflow enhancements and does not describe new disease indications, instead emphasizing technical improvements to the existing Focal One HIFU platform for prostate cancer focal therapy.

Is artificial intelligence already part of EDAP’s cleared functionality?

EDAP states that the new imaging engine supports the potential development of AI-driven algorithms to assist surgeons, indicating AI is a future development area supported by the cleared technology.