FDA Clears PROCEPT BioRobotics’ HYDROS Robotic System

PROCEPT BioRobotics Corporation has won U.S. Food and Drug Administration (FDA) 510(k) clearance for its next-generation platform, the HYDROS Robotic System.

“We are pleased to bring the HYDROS Robotic System to the U.S. market,” PROCEPT BioRobotics CEO Reza Zadno said. “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.”

Leveraging insights from more than 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.
 
“As a urologist, my goal is to treat my patients’ symptoms while preserving their quality of life. Aquablation therapy has been instrumental in helping me achieve this for patients struggling with BPH,” said Dr. Steven Kaplan, Icahn School of Medicine at Mount Sinai. “The HYDROS Robotic System advances this further by utilizing the power of AI to better read and interpret ultrasound for optimal surgical planning.”
 
The HYDROS Robotic System combines 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:

• 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.
• 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.
• 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.
• 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.
 
“The HYDROS Robotic System is a testament to our commitment to innovation. By integrating AI and advanced imaging into the robotic platform, we are providing surgeons with the tools they need to deliver precise, efficient, and high-quality care,” PROCEPT BioRobotics Chief Commercial Officer Sham Shiblaq stated. 
 
PROCEPT BioRobotics is a surgical robotics company developing transformative solutions in urology. The HYDROS Robotic System reportedly is the only AI-Powered, robotic technology that delivers Aquablation therapy. PROCEPT BioRobotics designed Aquablation therapy to deliver effective, safe, and durable outcomes for males suffering from lower urinary tract symptoms or LUTS, due to BPH that are independent of prostate size and shape or surgeon experience. BPH is the most common prostate disease and impacts approximately 40 million U.S. men. The company has developed a growing body of clinical evidence with more than 150 peer-reviewed publications, supporting the benefits and clinical advantages of Aquablation therapy.