The U.S. Food and Drug Administration granted 510(k) clearance on November 20 2025 for the latest version of EDAP TMS’s Focal One Robotic HIFU system, a milestone that validates the company’s recent platform enhancements and paves the way for broader U.S. adoption.
The clearance applies to the Focal One i platform, which debuted at the American Urological Association Annual Meeting in Las Vegas in April 2025. The updated system adds advanced ultrasound imaging, streamlined treatment‑planning software, and an optimized user interface, all of which improve real‑time visualization and workflow efficiency for prostate‑cancer procedures.
The approval also authorizes the integration of future AI‑driven algorithms, such as Unfold AI and OnQ Prostate, into the platform. These tools are designed to assist surgeons with lesion detection, margin assessment, and treatment planning, positioning EDAP at the forefront of AI‑enabled focal therapy.
EDAP’s Q2 2025 results show HIFU revenue of €8.5 million, a 76.8 % year‑over‑year increase, and 12 Focal One systems placed—up from nine in Q2 2024 and three in the same period a year earlier. The clearance is expected to accelerate this momentum by expanding the system’s capabilities and supporting new indications like deep‑infiltrating endometriosis and benign prostatic hyperplasia.
Strategically, the clearance reinforces EDAP’s pivot toward its high‑margin HIFU business. The company has raised its 2025 HIFU revenue‑growth guidance to 26‑34 % from 16‑25 % and secured a €36 million credit facility from the European Investment Bank to fund further development and commercialization. Net loss per share in Q2 2025 was €0.15 on €16 million in revenue, reflecting the company’s investment‑heavy growth strategy.
The focal‑therapy market is projected to reach $1.64 billion by 2033, with ultrasound‑based HIFU expected to capture a significant share. Key competitors include companies such as Sonabio, Lumenis, and InSightec, but EDAP’s early regulatory approvals and AI roadmap give it a competitive edge in the U.S. market.
CEO Ryan Rhodes said the clearance is a “technical milestone” that confirms the system’s enhanced imaging and AI readiness, and that it will “accelerate adoption and expand our reach into new therapeutic areas.”
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