FDA clearance of the HYDROS Robotic System, the next-generation, AI-powered platform for aquablation therapy – PROCEPT BioRobotics Corporation

PROCEPT BioRobotics Corporation announced FDA 510(k) clearance of its next-generation platform, the HYDROS Robotic System.

Leveraging insights from over 50,000 procedures, HYDROS features FirstAssist AI treatment planning, advanced image guidance, robotic resection, and a streamlined workflow. HYDROS is designed to improve efficiency, enhance surgeon and staff experience and deliver a more accurate and consistent treatment plan for better clinical outcomes.

“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.”

The HYDROS Robotic System represents the next evolution in the delivery of Aquablation therapy, combining cutting-edge technology with user-friendly features designed to deliver better clinical outcomes for patients and healthcare providers.

Key Features of the Fully Integrated HYDROS Robotic System Include : i. AI-Powered Treatment Planning: FirstAssist AI, built from a library of real-world Aquablation therapy procedures, uses advanced image recognition software to accurately identify critical anatomy on ultrasound and suggest an optimal treatment plan for each patient. ii. Advanced Image Guidance: The system integrates next-generation ultrasound imaging, digital cystoscopy, and dual high-definition touchscreens providing enhanced visualization of the anatomy and simultaneous viewing of ultrasound and cystoscopy images.
ii. Robotic Resection: Utilizing a heat-free waterjet, the robot executes the surgeon-defined treatment plan to resect obstructive tissue while protecting critical anatomy. This enables efficient and predictable waterjet execution, standardizing the operative experience across a wide range of prostate sizes and shapes.
iii. Streamlined Workflow: Designed to improve the surgeon and staff experience at every stage of the Aquablation therapy procedure. With a single-footprint, the integrated tower facilitates efficient operating room setup and turnover. The adjustable touchscreen improves surgeon ergonomics with midline placement, and the instinctive software interface simplifies procedural workflow.

“The HYDROS Robotic System is a game-changer for new surgeons. I believe the streamlined system along with the system’s intraoperative AI capabilities provide a tool to suggest an optimal treatment, helping surgeons learn the procedure faster and with greater precision,” said Dr. Brian Helfand, NorthShore’s Chief of Urology and Clinical Professor at the University of Chicago.