Procept: FDA Investigational Device Exemption for Aquablation® Therapy for Prostate Cancer

 PROCEPT BioRobotics Corporation (NASDAQ: PRCT) (“PROCEPT BioRobotics”), a global leader in surgical robotics, announced today the Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to investigate the safety and efficacy of Aquablation therapy for prostate cancer.

The IDE approval allows PROCEPT BioRobotics to initiate a single-arm feasibility study in the United States. The data generated from this IDE study will support future research and regulatory applications in the United States. The study will enroll patients with localized prostate cancer at three prestigious cancer centers, Keck Medical Center of USC, Perlmutter Cancer Center at NYU Langone Health, and Mount Sinai Tisch Cancer Center.

https://finance.yahoo.com/news/procept-biorobotics-receives-u-fda-120000969.html