EDAP TMS shares surge 11.66% intraday after FDA clears enhanced Focal One HIFU system.

EDAP TMS surged 11.66% intraday after announcing FDA 510(k) clearance for enhanced imaging and workflow features in its Focal One HIFU system. The clearance introduces real-time visualization, streamlined treatment planning, and AI-driven algorithm potential, strengthening the company’s leadership in robotic prostate cancer therapies. The update underscores EDAP’s innovation in focal therapy, with CEO Ryan Rhodes emphasizing its significance for the product roadmap. The approval is expected to enhance treatment efficiency and market competitiveness, aligning with the stock’s sharp intraday gains as investors reacted positively to the regulatory milestone and future growth prospects.