Avenda Health Earns Breakthrough Designation for Prostate Cancer Laser System
Avenda Health has received Breakthrough Device designation from the FDA for its Focal Therapy System, a laser device that targets and treats prostate tumors.
The device is being evaluated as a treatment for use in a urologist’s office under local anesthesia. It uses a laser in conjunction with an optical and thermal sensor to precisely target and treat prostate tumors.
The system has received 510(k) clearance for ablation of soft tissue, but is not yet commercially available as Avenda conducts clinical trials to support premarket approval for treating localized prostate cancer.