Summary: Procept BioRobotics has received FDA 510(k) clearance for its Hydros Robotic System, which integrates AI and advanced imaging for improved urology procedures. The system is designed to enhance efficiency and clinical outcomes, and it will soon be available in U.S. hospitals.

Key Takeaways:

  • Procept BioRobotics’ Hydros Robotic System received FDA 510(k) clearance.
  • The system leverages AI and advanced imaging for enhanced precision in urology procedures.
  • Hydros will be fully released to U.S. hospitals within the current quarter.

Procept BioRobotics Corporation, a surgical robotics company focused on developing transformative solutions in urology, has nabbed U.S. 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.

Market Introduction

“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.”

Key Features of the Hydros Robotic System

  • 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.

Commitment to Innovation and Market Release

“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,” said Sham Shiblaq, chief commercial officer at Procept BioRobotics. “Hydros will move to full market release within the current quarter and be available immediately to hospitals across the United States.”