EDAP Receives FDA 510(k) Clearance for Advanced Focal One Robotic HIFU System Enhancements

EDAP TMS SA has received FDA 510(k) clearance for new enhancements to its Focal One Robotic High Intensity Focused Ultrasound (HIFU) system315.

The clearance covers advanced ultrasound imaging, optimized user interface, and streamlined treatment planning for the Focal One i system145.

The new ultrasound imaging engine enables real-time visualization and supports the future development of AI-driven algorithms to assist surgeons with tissue ablation evaluation1.

Focal One is a robotic HIFU platform primarily used for minimally invasive focal therapy in prostate cancer treatment, and these updates further improve its workflow and user experience14.

This clearance represents a significant regulatory milestone for EDAP's robotic HIFU technology, enhancing its competitiveness in the urology device market1.

Sources:

1. https://www.investing.com/news/company-news/edap-receives-fda-clearance-for-enhanced-focal-one-robotic-hifu-system-93CH-4370171

3. https://www.globenewswire.com/news-release/2025/11/20/3191788/9622/en/EDAP-Receives-FDA-510-k-Clearance-for-Latest-Evolution-of-Focal-One-Robotic-HIFU.html

4. https://www.massdevice.com/edap-fda-nod-robotic-hifu-system/

5. https://www.mpo-mag.com/breaking-news/edap-wins-fda-nod-for-latest-version-of-focal-one-hifu/