Procept BioRobotics said today that it won de novo clearance from the FDA for its Aquabeam device for treating benign prostate hyperplasia, saying it plans to have the device on the U.S. market early next year.
Redwood Shores, Calif.-based Procept said the federal safety watchdog used the 181-patient Water study to inform its decision. The trial, comparing Aquablation with transurethral resection of the prostate, showed equivalent efficacy and a better safety profile, including a reduction in sexual side effects by a ratio of four to one.
Get the full story at our sister site, The Robot Report.
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