Edap Tms SA 6-K Filing
Ticker: EDAP · Form: 6-K · Filed: Nov 20, 2025 · CIK: 1041934
| Field | Detail |
|---|---|
| Company | Edap Tms SA (EDAP) |
| Form Type | 6-K |
| Filed Date | Nov 20, 2025 |
| Pages | 3 |
| Reading Time | 3 min |
| Sentiment | neutral |
Sentiment: neutral
FAQ
What type of filing is this?
This is a 6-K filing submitted by Edap Tms SA (ticker: EDAP) to the SEC on Nov 20, 2025.
How long is this filing?
Edap Tms SA's 6-K filing is 3 pages with approximately 778 words. Estimated reading time is 3 minutes.
Where can I view the full 6-K filing?
The complete filing is available on SEC EDGAR. You can also read the AI-decoded analysis with risk assessment and key highlights on ReadTheFiling.
Filing Stats: 778 words · 3 min read · ~3 pages · Grade level 15.2 · Accepted 2025-11-20 07:33:04
Filing Documents
- f6k_112025.htm (6-K) — 14KB
- 0001171843-25-007449.txt ( ) — 16KB
SIGNATURES
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 pros