Procept BioRobotics (PRCT) said Monday that it has received approval from the US Food and Drug Administration for an investigational device exemption clinical trial to compare Aquablation therapy with radical prostatectomy.
The study will enroll up to 280 patients at up to 50 centers and follow them for 10 years, the company said. It recently received Breakthrough Device Designation to investigate the use of Aquablation therapy for prostate cancer.
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