EDAP Receives FDA 510(k) Clearance for Latest Evolution of Focal One Robotic HIFU
EDAP (Nasdaq: EDAP) announced that the U.S. Food and Drug Administration granted 510(k) clearance on November 20, 2025 for ultrasound imaging and workflow enhancements to the Focal One High Intensity Focused Ultrasound (HIFU) system.
The clearance covers an upgraded ultrasound imaging engine, streamlined treatment planning and an optimized user interface for the Focal One i, enabling real-time visualization and supporting potential future AI-driven algorithms to assist surgeons with tissue ablation visualization and treatment evaluation.
Company commentary cites this clearance as a technical milestone that reinforces Focal One’s market leadership in robotic focal therapy for prostate cancer.
EDAP (Nasdaq: EDAP) ha annunciato che la FDA statunitense ha concesso l’autorizzazione 510(k) il 20 novembre 2025 per l’imaging a ultrasuoni e i miglioramenti del flusso di lavoro al sistema Focal One High Intensity Focused Ultrasound (HIFU).
L’autorizzazione riguarda un motore di imaging a ultrasuoni aggiornato, una pianificazione del trattamento snellita e un’interfaccia utente ottimizzata per il Focal One i, abilitando la visualizzazione in tempo reale e supportando potenziali futuri algoritmi guidati dall’IA per assistere i chirurghi nella visualizzazione dell’ablazione tissutale e nella valutazione del trattamento.
Il commento dell’azienda cita questa autorizzazione come una tappa tecnica che rafforza la leadership di mercato di Focal One nel trattamento focal robotico per il cancro alla prostata.
EDAP (Nasdaq: EDAP) anunció que la Administración de Alimentos y Medicamentos de EE. UU. concedió la autorización 510(k) el 20 de noviembre de 2025 para mejoras de imagen por ultrasonido y flujo de trabajo en el sistema Focal One High Intensity Focused Ultrasound (HIFU).
La autorización cubre un motor de imagen por ultrasonido mejorado, planificación de tratamiento optimizada y una interfaz de usuario para el Focal One i, que permiten visualización en tiempo real y respaldan posibles algoritmos futuros impulsados por IA para ayudar a los cirujanos con la visualización de la ablación del tejido y la evaluación del tratamiento.
Los comentarios de la empresa citan esta autorización como un hito técnico que refuerza el liderazgo de Focal One en la terapia focal robótica para el cáncer de próstata.
EDAP (나스닥: EDAP)은 미국 식품의약국(FDA)이 2025년 11월 20일에 Focal One 고강도 집속 초음파(HIFU) 시스템의 초음파 영상 및 작업 흐름 향상을 위한 510(k) 승인을 부여했다고 발표했습니다.
승인은 고급 초음파 영상 엔진, 간소화된 치료 계획 및 Focal One i를 위한 최적화된 사용자 인터페이스를 포함하며 실시간 가시화를 가능케 하고, 조직 절제 시각화 및 치료 평가를 지원하기 위한 잠재적 미래 AI 기반 알고리즘을 지원합니다.
회사 논평은 이 승인를 Focal One의 전립선암 로봇 초점 치료에서의 시장 리더십을 강화하는 기술적 이정표로 인용합니다.
EDAP (Nasdaq: EDAP) a annoncé que la Food and Drug Administration américaine a accordé l’autorisation 510(k) le 20 novembre 2025 pour l’imagerie par échographie et les améliorations du flux de travail du système Focal One High Intensity Focused Ultrasound (HIFU).
Cette autorisation couvre un moteur d’imagerie par ultrasons amélioré, une planification du traitement rationalisée et une interface utilisateur optimisée pour le Focal One i, permettant la visualisation en temps réel et soutenant d’éventuels algorithmes futurs pilotés par l’IA pour aider les chirurgiens à la visualisation de l’ablation tissulaire et à l’évaluation du traitement.
Les commentaires de l’entreprise citent cette autorisation comme une étape technique renforçant la position de leader sur le marché de la thérapie focal robotisée pour le cancer de la prostate.
EDAP (Nasdaq: EDAP) kündigte an, dass die US-amerikanische Food and Drug Administration am 20. November 2025 eine 510(k)-Freigabe für die Ultraschallbildgebung und den Workflow des Focal One High Intensity Focused Ultrasound (HIFU) Systems erteilt hat.
Die Freigabe deckt eine verbesserte Ultraschallbildgebung, eine optimierte Behandlungsplanung und eine optimierte Benutzeroberfläche für den Focal One i ab, wodurch eine Echtzeit-Visualisierung ermöglicht wird und potenzielle zukünftige KI-gesteuerte Algorithmen zur Unterstützung von Chirurgen bei der Gewebeablation-Visualisierung und der Behandlungsbewertung vorgesehen werden.
Das Unternehmenskommentar bezeichnet diese Freigabe als technischen Meilenstein, der die Marktführerschaft von Focal One in der roboterassistierten fokalen Therapie für Prostatakrebs stärkt.
EDAP (Nasdaq: EDAP) أعلنت أن إدارة الغذاء والدواء الأمريكية منحت إقرار 510(k) في 20 نوفمبر 2025 لتصوير بالموجات فوق الصوتية وتحسينات سير العمل في نظام Focal One High Intensity Focused Ultrasound (HIFU).
يغطي الإقرار محرك تصوير بالموجات فوق الصوتية مُحدث، وتخطيط علاج مُبسّط وقاعدة واجهة مستخدم مُحسّنة لـ Focal One i، مما يتيح التصور في الوقت الفعلي ويدعم خوارزميات مستقبلية مدفوعة بالذكاء الاصطناعي لمساعدة الجراحين في تصور استئصال الأنسجة وتقييم العلاج.
تشير تعليقات الشركة إلى أن هذا الإقرار يمثل علامة فنية تعزز ريادة Focal One في العلاج الموضعي الروبوتي لسرطان البروستاتا.
- Received FDA 510(k) clearance for Focal One imaging and workflow enhancements
- Introduced a next-generation ultrasound imaging engine with real-time visualization
- System update includes streamlined treatment planning and optimized user interface
- Clearance covers imaging and workflow enhancements, not a new therapeutic indication
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
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