The US Food and Drug Administration (FDA) has issued 510(k) clearance for Procept Biorobotics’ Hydros Robotic System, which aims to deliver Aquablation therapy.

The therapy delivers effective, safe, and durable outcomes for males with lower urinary tract symptoms (LUTS), due to benign prostatic hyperplasia (BPH).

Hydros is a next-generation, AI-powered platform, designed for improved efficiency and consistency for Aquablation therapy.

It integrates FirstAssist AI treatment planning, robotic precision and advanced imaging to deliver a streamlined and enhanced surgical experience.

FirstAssist AI is developed from a vast library of real-world Aquablation procedures. Employing advanced image recognition, it can accurately identify critical anatomy on ultrasound, proposing an optimal treatment plan tailored to each patient.

The robotic system's advanced image guidance combines next-generation ultrasound with digital cystoscopy, allowing surgeons to view high-definition images of the anatomy.

The robot's dual touchscreens facilitate the simultaneous monitoring of ultrasound and cystoscopy images, providing a comprehensive visual aid during surgery.

Hydros' robotic resection capability utilises a heat-free water jet, guided by the surgeon-defined treatment plan, to precisely remove obstructive tissue.

The technology ensures the protection of critical anatomy, enabling a consistent procedure across various prostate sizes and shapes.

Furthermore, the Hydros Robotic System streamlines the workflow of Aquablation therapy. Its integrated tower and single-footprint design optimise operating room setup and turnover.

Procept BioRobotics chief commercial officer Sham Shiblaq said: “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.

“Hydros will move to full market release within the current quarter and be available immediately to hospitals across the United States.”