Advancements in Minimally Invasive Prostate Cancer Therapies: The Emerging Role of Focal One HIFU

The Focal One HIFU system received FDA 510(k) clearance, advancing image‑guided prostate ablation with improved ultrasound imaging and a streamlined workflow. The clearance covers technical upgrades without expanding the therapeutic indication, and the net clinical implication is preserved urinary continence and erectile function for appropriately selected patients.

That evidence frames focal ablation as a tissue‑sparing alternative to whole‑gland treatment for men with localized disease who prioritize function while maintaining oncologic control. Refinements in imaging and planning increase procedural precision and may reduce the need for repeat treatments. The clearance reiterates a technical improvement rather than a change in intended use.

Randomized data from the FARP trial compared focal ablation with radical prostatectomy, using treatment‑failure rate at 36 months as the primary endpoint. The study met its prespecified noninferiority margin for treatment failure and showed better urinary continence and erectile function preservation in the focal‑ablation arm; crossover from the surgery arm to focal therapy was reported. Within the trial’s defined cohorts, oncologic outcomes were comparable at medium‑term follow‑up, supporting focal ablation for men who prioritize function without apparent compromise in medium‑term control.

Technical upgrades include improved ultrasound imaging that clarifies lesion margins, a streamlined user interface that shortens intraoperative mapping time, and enhanced treatment‑planning tools that promote more consistent target coverage. By reducing planning and treatment variability, these refinements translate to faster case turnover, potentially fewer repeat ablations, and clearer intraoperative decision checkpoints. The device is cleared for clinical use with these enhancements while remaining within the existing therapeutic scope.