Core Insights - EDAP TMS SA has received FDA 510(k) clearance for enhancements to the Focal One High Intensity Focused Ultrasound (HIFU) system, reinforcing its leadership in robotic focal therapy for prostate cancer [1][2][3] Product Enhancements - The new clearance introduces advanced ultrasound imaging, streamlined treatment planning, and an optimized user interface to the Focal One i system [2] - The next-generation ultrasound imaging engine offers real-time visualization and supports the development of AI-driven algorithms for tissue ablation visualization and treatment evaluation [2] Company Commitment - The CEO of EDAP TMS expressed pride in the new FDA clearance, highlighting it as a significant technical milestone and a testament to the company's commitment to innovation in focal therapy [3] - EDAP TMS is recognized as a leader in robotic energy-based therapies, developing minimally invasive medical devices using ultrasound technology [3]