Procept BioRobotics received FDA 510(k) clearance for its next-generation Hydros robotic surgery system. Hydros delivers the San Jose, California-based company’s Aquablation therapy. The company received FDA investigational device exemption (IDE) for its Aquablation procedure in September 2023. Aquablation uses waterjet resection to precisely eradicate prostate tissue. It provides the potential for an effective cancer treatment while maintaining the patient’s quality of life.
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The image-guided, automated, heat-free robotic therapy uses real-time ultrasound imaging. This provides the surgeon with a multi-dimensional view of the prostate. Aquablation therapy enables personalized treatment planning tailored to each patient’s unique anatomy, Procept Biorobotics says.
Procept Biorobotics’ Hydros robotic system leverages insights from more than 50,000 procedures. It features FirstAssist AI treatment planning, advanced image guidance, robotic resection and a streamlined workflow. The company designed it to improve efficiency, enhance surgeon and staff experience and deliver a more accurate and consistent treatment plan.
Hydros’ advanced image guidance integrates next-generation ultrasound, digital cytoscopy and dual high-definition touchscreens. These provide enhanced visualization of the anatomy and simultaneous ultrasound and cytoscopy imaging. The system’s robotic resection capabilities use a heat-free waterjet to resect obstructive tissue while protecting critical anatomy.
“We are pleased to bring the Hydros robotic system to the U.S. market,” said Reza Zadno, CEO of Procept BioRobotics. “This milestone marks a pivotal moment for Procept as Aquablation therapy continues its rapid adoption, with over 400 robotic systems now installed across the United States.
“After years of research and development, Hydros introduces significant technological advancements designed for mass-market adoption, and we believe will power the next phase of our growth.”
