Surgical robotics company Procept BioRobotics has received the US Food and Drug Administration (FDA) 510(k) clearance for the HYDROS Robotic System.
HYDROS Robotic System is the next-generation, artificial intelligence (AI)-powered platform, designed for the delivery of Aquablation therapy.
The system is designed to provide effective, safe, and long-lasting relief for men with lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH).
In September last year, Nasdaq-listed Procept BioRobotics secured the FDA investigational device exemption (IDE) for its Aquablation procedure.
The procedure combines real-time ultrasound imaging with cystoscopy, giving the surgeon a detailed, multi-dimensional view of the prostate. It allows for personalised treatment planning tailored to each patient’s anatomy.
Aquablation therapy is supported by two five-year clinical trials, which showed long-lasting symptom relief while preserving sexual function and continence.
Drawing on insights from over 50,000 procedures, HYDROS integrates FirstAssist AI for treatment planning, advanced image guidance, robotic resection, and a streamlined workflow.
The design aims to boost efficiency, enhance the experience for surgeons and staff, and provide a more accurate and consistent treatment plan for improved clinical outcomes.
The system advances Aquablation therapy using advanced technology with intuitive features to achieve more clinical outcomes for both patients and healthcare providers.
HYDROS Robotic System offers a range of advanced features like AI-powered treatment planning using FirstAssist AI.
The AI platform uses a library of real-world Aquablation therapy procedures and image recognition to identify critical anatomy on ultrasound and recommend optimal treatment plans.
The system integrates advanced ultrasound imaging, digital cystoscopy, and dual high-definition touchscreens for visualisation and simultaneous viewing of images.
In addition, its heat-free waterjet technology allows the robot to follow the surgeon’s treatment plan with precision. It resects tissue while safeguarding critical structures and accommodating various prostate sizes and shapes.
Designed for efficiency, the system’s single footprint and integrated tower streamline operating room setup and turnover.
Furthermore, the presence of an adjustable touchscreen enhances ergonomics, and the intuitive software interface simplifies the procedural workflow.
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 US.
“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.”
