FDA grants 510(k) clearance to new edition of Focal One robotic HIFU

The FDA has granted 510(k) clearance to new ultrasound imaging and workflow enhancements for the Focal One high-intensity focused ultrasound (HIFU) system for robotic focal therapy for prostate cancer, EDAP announced in a news release.¹

The Focal One system was initially granted 510(k) clearance by the FDA in 2018.

These new enhancements add on to the Focal One i, which was launched earlier this year at the American Urological Association (AUA) Annual Meeting in Las Vegas, Nevada. With this clearance, the system will now include advanced ultrasound imaging, streamlined treatment planning, and an optimized user-interface. The system also supports the potential for artificial intelligence-driven algorithms that could assist surgeons in tissue ablation visualization and treatment evaluation.

“We are proud to receive this new FDA clearance, which further enhances the capabilities of the new Focal One i and represents another important technical milestone in Focal One’s product roadmap,” said Ryan Rhodes, Chief Executive Officer of EDAP TMS, in the news release.¹ “This achievement demonstrates our team’s continued commitment to innovation and reinforces Focal One’s global leadership in focal therapy.”

Data on Focal Ablation

The effectiveness of focal ablation has been demonstrated across several key studies, including the randomized controlled FARP trial (NCT03668652), which also read out at the AUA 2025 meeting. The study enrolled a total of 213 patients who were randomly assigned to receive focal ablation (n = 107) or radical prostatectomy (n = 106). In total, 25% of patients (26 of 106) in the prostatectomy arm refused surgery and crossed over to the focal ablation arm. The Focal One Robotic system was used in the majority of procedures in the focal ablation arm, according to EDAP.²

Overall, the study met its primary end point by showing that focal ablation was non-inferior to radical prostatectomy in regard to the rate of treatment failure at the final 36-month follow-up. Specifically, the rate of treatment failure was 5.6% (95% CI, 3 to 13) in the focal ablation arm compared with 7.9% (95% CI, 5 to 15) in the radical prostatectomy arm (difference, 2.3%; 95% CI, -4.9 to 9.9).

HIFU has also been compared with radical prostatectomy in the prospective HIFI trial (NCT04307056).³ The trial included a total of 3328 patients, of whom 1967 received HIFU and 1361 received radical prostatectomy.

The study also met its primary end point, demonstrating the non-inferiority of HIFU vs radical prostatectomy regarding the salvage treatment-free survival (STFS) rate. At 30 months, 90% of patients in the HIFU arm vs 86% of patients in the radical prostatectomy arm remained free from salvage treatment.

The study also showed favorable urinary continence and erectile function preservation at 12 months. Specifically, data showed an 11% difference in the pad-free continence rate, favoring the HIFU arm. The rate of deterioration in the International Continence Society index was 29% in the HIFU arm vs 44% in the surgery arm (RR, 0.66; 95% CI, 0.59 to 0.74; P < .001). Further, the decrease in erectile function from baseline to 12 months was -7 in the HIFU arm vs -13 in the radical prostatectomy arm.

Although the authors noted that longer follow-up was needed, they concluded, “This large prospective trial demonstrates that whole-gland or subtotal HIFU provides comparable medium-term STFS outcomes to RP. Urinary continence and erectile function were less impaired after HIFU.”

REFERENCES

1. EDAP receives FDA 510(k) clearance for latest evolution of Focal One Robotic HIFU. News release. EDAP TMS. November 20, 2025. Accessed November 20, 2025. https://investor.focalone.com/news-releases/news-release-details/edap-receives-fda-510k-clearance-latest-evolution-focal-one

2. EDAP announces positive results from the FARP randomized controlled trial presented at the American Urological Association (AUA) Annual Meeting. News release. EDAP TMS. April 29, 2025. Accessed November 20, 2025. https://investor.focalone.com/news-releases/news-release-details/edap-announces-positive-results-farp-randomized-controlled-trial

3. Ploussard G, Coloby P, Chevallier T, et al. Whole-gland or subtotal high-intensity focused ultrasound versus radical prostatectomy: The prospective, noninferiority, nonrandomized HIFI trial. Eur Urol. 2025;87(5):526-533. doi:10.1016/j.eururo.2024.11.006