EDAP TMS SA Receives FDA 510(k) Clearance for Enhanced Focal One Robotic HIFU System
Edap TMS SA has received FDA 510(k) clearance for enhancements to its Focal One HIFU system, including advanced imaging and workflow improvements. This approval strengthens its position in robotic focal therapy for prostate cancer.
Edap TMS SA has received FDA 510(k) clearance for new ultrasound imaging and workflow enhancements to its Focal One High Intensity Focused Ultrasound (HIFU) system. The clearance includes advanced ultrasound imaging, streamlined treatment planning, and an optimized user interface for the Focal One i, supporting real-time visualization and the potential development of AI-driven algorithms for tissue ablation and treatment evaluation. This regulatory approval further strengthens Edap TMS SA’s position in robotic focal therapy for prostate cancer. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Edap TMS SA published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW1001139958-en) on November 20, 2025, and is solely responsible for the information contained therein. © Copyright 2025 - Public Technologies (PUBT)
