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

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Last update: Nov 20, 2025

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.