EDAP TMS, a company specializing in robotic energy-based therapies, has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for ultrasound imaging and workflow enhancements to its Focal One High Intensity Focused Ultrasound (HIFU) system.

The clearance introduces advanced ultrasound imaging, streamlined treatment planning, and an optimized user interface to the Focal One i launched earlier this year. The next-gen ultrasound imaging engine offers real-time visualization and supports potential development of artificial intelligence (AI)-driven algorithms designed to help surgeons with tissue ablation visualization and treatment evaluation.

This FDA nod further bolsters the company’s market leadership in robotic focal therapy for prostate cancer. EDAP introduced the Focal One in Europe and the U.S. as a prostate focal therapy controlled by urologists, with the potential to grow to multiple indications beyond prostate cancer.

“We are proud to receive this new FDA clearance, which further enhances the capabilities of the new Focal One and represents another important technical milestone in Focal One’s product roadmap,” said Ryan Rhodes, CEO of EDAP TMS. “This achievement demonstrates our team’s continued commitment to innovation and reinforces Focal One’s global leadership in focal therapy.”

Focal One achieved FDA breakthrough designation last year as well. It was cleared for ablation of prostatic tissue in 2018.