HYDROS Handpiece

by Procept Biorobotics  · Based in United States → — Advancing patient care by developing transformative solutions in urology.
Urology
Website
Claim this tool
Is this the maker? Claim the company →

Regulatory Status Disclosed

Overview

The HYDROS Handpiece is a critical, single-use component of the HYDROS Robotic System by Procept Biorobotics. This advanced, AI-powered surgical robotic system is designed for Aquablation therapy, a minimally invasive procedure for the treatment of benign prostatic hyperplasia (BPH). While the prompt requested information for an “AI tool for a physician directory,” the HYDROS Handpiece and its associated system are medical devices with integrated artificial intelligence.

The HYDROS Robotic System leverages AI-powered treatment planning with FirstAssist AI™, advanced image guidance (including next-generation ultrasound imaging, digital cystoscopy, and dual high-definition touchscreens), and robotic-assisted, heat-free waterjet resection. This combination allows for personalized treatment planning tailored to each patient’s unique anatomy, aiming to deliver significant and lasting symptom relief while preserving sexual function and continence. The system is designed to enhance efficiency, improve surgeon and staff experience, and provide accurate and consistent treatment plans for better clinical outcomes in urologic surgery.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered treatment planning with FirstAssist AIu2122
  • Advanced image guidance (ultrasound, digital cystoscopy, HD touchscreens)
  • Robotic-assisted, heat-free waterjet resection
  • Streamlined workflow for enhanced efficiency
  • Personalized treatment planning tailored to patient anatomy
  • Designed to preserve sexual function and continence
  • Single-use sterile surgical handpiece
  • Precise and rapid removal of prostate tissue

Use Cases

  • Treatment of benign prostatic hyperplasia (BPH)
  • Resection and removal of prostate tissue
  • Minimally invasive urologic surgery
  • Procedures in outpatient settings

What Physicians Need to Know

Surgical Planning Capabilities
The HYDROS Robotic System, which includes the HYDROS Handpiece, features AI-powered treatment planning with 'FirstAssist AIu2122'. This advanced image recognition software identifies critical anatomy on ultrasound and suggests an optimal, personalized treatment plan. Surgeons can then refine resection angles and depths under real-time ultrasound guidance to maximize tissue removal while sparing vital structures like the bladder neck, verumontanum, and external sphincter.
Intraoperative Guidance
The system provides advanced, real-time image guidance through next-generation ultrasound imaging and digital cystoscopy. Dual high-definition touchscreens allow for enhanced visualization of the anatomy and simultaneous viewing of both ultrasound and cystoscopy images. The integrated digital cystoscope offers higher resolution video and a wider field of view, enabling surgeons to precisely map areas for tissue removal and avoidance.
Robotic Surgery Integration
The HYDROS Handpiece is a single-use sterile surgical device integrated into the HYDROS Robotic System, an advanced, image-guided surgical robot. The system performs robotic-assisted, heat-free waterjet resection, precisely executing the surgeon-defined treatment plan for predictable and consistent tissue removal.
Surgical Navigation Accuracy
The HYDROS Robotic System is designed for high surgical navigation accuracy. Its AI-powered planning and real-time image guidance, combined with robotic execution of the heat-free waterjet, ensure precise targeting and removal of prostate tissue. This approach aims to deliver a more accurate and consistent treatment plan, enhancing overall precision and predictability.
Operating Room Workflow Integration
The HYDROS Robotic System is engineered for a streamlined workflow to enhance efficiency and improve the surgeon and staff experience. It features an integrated tower, an adjustable touchscreen for improved ergonomics with mid-line placement, and an intuitive software interface that provides step-by-step guidance, simplifying the procedural workflow.
Physician Tip

Leverage the 'FirstAssist AIu2122' for initial treatment planning, but always review and customize the plan based on the patient's unique anatomy and your surgical judgment. Utilize the dual high-definition screens for simultaneous ultrasound and cystoscopy views to ensure comprehensive intraoperative guidance and precise targeting. Emphasize the heat-free waterjet technology to patients as a benefit for preserving critical anatomy and reducing potential complications like erectile or ejaculatory dysfunction and incontinence.

The HYDROS Handpiece is a critical single-use component of the HYDROS Robotic System. It integrates seamlessly with the system's AI-powered software, advanced ultrasound imaging (via the HYDROS TRUS Probe), digital cystoscopy, and robotic arm to deliver Aquablation therapy for benign prostatic hyperplasia (BPH). The system's components work in concert to provide real-time visualization, personalized planning, and precise robotic resection.

Details

Category Surgical AI
Pricing Unknown
DeploymentHospital, Surgical Centers
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The HYDROS Robotic System, which includes the HYDROS Handpiece, received U.S. FDA 510(k) clearance (K240200) in August 2024. It is indicated for the resection and removal of prostate tissue in males suffering from lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH).
Integrations
EHR Not specified
Specialties Urology

Ratings & Reviews

No reviews yet. Be the first to review this tool!

Rate HYDROS Handpiece

Clinical Value
Ease of Use
Integration
Support & Docs
Value for Money

Press & Coverage

Seeking Alpha
PROCEPT BioRobotics Corporation (PRCT) Q4 2024 Earnings Call Transcript
PROCEPT BioRobotics discussed the strong market reception of its HYDROS Handpiece in their Q4 2024 earnings call, noting its preassembled single-use digital scope eliminates the need for cystoscope reprocessing, enhancing efficiency and saving costs for hospitals. The HYDROS system, cleared by the FDA in August 2024, also features FirstAssist AI for precise targeting during Aquablation therapy.
2025-02
Notes From The Beauty Contest (Substack)
Procept Biorobotics (PRCT) - by Crashkolnikov - Notes From The Beauty Contest
This article highlights the upgrades introduced with the HYDROS system, including AI-powered treatment planning, next-generation ultrasound and digital cystoscopy, and a redesigned interface for improved usability. The complete single-use HYDROS Handpiece eliminates the need for hospitals to reprocess equipment, and its average selling price is higher than the previous AquaBeam handpiece.
2026-01
FDA
510(k) Premarket Notification - FDA
This FDA document details the 510(k) Premarket Notification for the HYDROS Robotic System, which includes the HYDROS Handpiece (HH1000) and HYDROS TRUS Probe (HU1000), submitted by Procept Biorobotics. The system is intended for the resection and removal of prostate tissue in males with lower urinary tract symptoms due to benign prostatic hyperplasia.
2026-07
FDA
August 20, 2024 Procept BioRobotics Sara Muddell Sr. Director, Global Regulatory Affairs 150 Baytech Drive San Jose, California - accessdata.fda.gov
This FDA letter confirms the 510(k) clearance for the HYDROS Robotic System, comprising the HYDROS Robotic System, HYDROS TRUS Probe, and HYDROS Handpiece, on August 20, 2024. The system is indicated for the resection and removal of prostate tissue in males suffering from LUTS due to BPH.
2024-08
Innolitics
2025 Year in Review: Cardiology AI/ML SaMD 510(k) Clearances - Innolitics
This review of 2025 FDA 510(k) clearances for AI/ML-enabled medical devices lists the HYDROS Robotic System, HYDROS Handpiece, and HYDROS TRUS Probe from Procept BioRobotics with a clearance date of April 9, 2025, and a listing date of October 10, 2025. The article provides an overview of AI/ML trends in medical device approvals.
2026-01
StreetInsider.com
Procept Biorobotics at Leerink Conference: Strategic Growth and Challenges
During the Leerink Global Healthcare Conference 2025, Procept BioRobotics discussed the higher average selling prices of the HYDROS Handpiece compared to the AquaBeam and the positive feedback on the HYDROS system's efficiency due to its single-use scope. The company anticipates significant revenue growth in 2025, driven by new product launches like HYDROS.
2025-03
Stock Titan
PROCEPT BioRobotics (NASDAQ: PRCT) posts 2025 revenue growth but remains unprofitable - Stock Titan
PROCEPT BioRobotics' 2025 annual report highlights the HYDROS Handpiece's pre-assembled single-use digital scope, which eliminates reprocessing and contributes to safe and effective outcomes for BPH patients. The company reported an installed base of 912 AquaBeam and HYDROS robotic systems globally by the end of 2025.
2026-02
FXStreet
Earnings call: PROCEPT BioRobotics reported a revenue increase of 66%
In Q3 2024, PROCEPT BioRobotics reported a 74% increase in U.S. handpiece and consumable revenue, driven by the increased installed base of robotic systems and higher monthly utilization. The HYDROS handpiece, with its single-use digital scope, was noted for streamlining setup and saving time and money for hospitals.
2024-10

Videos

Product demos, reviews, and walkthroughs for HYDROS Handpiece.

View all on YouTube

Frequently Asked Questions

The FirstAssist AI, built from a library of real-world Aquablation procedures, uses advanced image recognition to identify critical anatomy on ultrasound and propose a patient-specific treatment plan. This AI-powered planning, combined with robotic precision and advanced imaging, aims to deliver more accurate and consistent treatment, potentially improving patient outcomes for BPH.
The HYDROS Robotic System, including the Handpiece, has received 510(k) clearance from the FDA, indicating it is substantially equivalent to a predicate device for its intended use. While the AI is built from a library of real-world procedures, specific details on patient data handling and privacy protocols were not explicitly detailed in the provided information, though general medical device regulations regarding quality systems and adverse event reporting apply.
Alternatives for treating BPH include traditional surgical procedures like Transurethral Resection of the Prostate (TURP), as well as other minimally invasive treatments. The HYDROS Robotic System offers Aquablation therapy, which uses a heat-free water jet for tissue removal.
The HYDROS Handpiece is a single-use device, with an average selling price estimated at approximately $3,200. The entire HYDROS Robotic System, which the handpiece integrates with, has an average selling price of approximately $435,000 per system.
Potential perioperative risks of Aquablation therapy with the HYDROS system include, but are not limited to, bladder or prostate capsule perforation, bleeding, infection, and sexual dysfunction. The system's user manual also warns against moving the handpiece or TRUS probe after registration, as this could lead to patient injury due to unanticipated tissue resection.
While the HYDROS Robotic System utilizes AI for treatment planning, the surgeon maintains control throughout the entire resection procedure. The AI assists in identifying critical anatomy and developing a plan, but adjustments can be made by the surgeon under real-time ultrasound guidance.
The HYDROS system is designed to be suitable for use by a larger number of surgeons, with its AI acting as a 'virtual ultrasound expert' to help interpret images and improve accuracy for both novice and experienced users. While specific training duration isn't detailed, the streamlined workflow and AI assistance aim to enhance efficiency and improve the surgeon experience.

Related Tools

IntelliLogic Ai
IntelliLogic AI
Surgical AI
IntelliLogic AI is an AI-powered operating system for medical device distribution, unifying surgical cases, field inventory, chargesheets, commissions, and analytics into a single, HIPAA-ready platform.
Tailored to team size, module mix, and integrations.
XACT ACE Robotic
XACT Robotics
Radiology & Imaging AI
The XACT ACE® Robotic System is the world's first and only comprehensive robotic system that combines image-guided planning and real-time monitoring with precise robotic insertion and S-Drive™ technology to deliver various instruments to a desired target in the body with unparalleled accuracy, unmatched consistency, and unlimited efficiency.
Proximie
Proximie Inc.
Clinical Decision Support & Reference
Proximie connects everything in the OR—people, data, and devices—to improve surgical throughput and quality through real-time, AI-powered insight and orchestration.
Proprio Paradigm
Proprio
Clinical Decision Support & Reference
Proprio Paradigm is an FDA-cleared, AI-powered surgical navigation platform that uses advanced sensors, computer vision, and AI to create real-time 3D models of anatomy, improving precision and streamlining workflows.
Contact sales
ExcelsiusGPS
Globus Medical
Neurology AI
ExcelsiusGPS™ is the first and only robotic navigation platform on the market that offers a comprehensive approach to spine and cranial procedures, from start to finish. The system enables repeatable and accurate trajectory alignment and navigation for placing screws, interbody implants, and cranial instruments.
Paid
OrthoPlan
OrthoPlan
Clinical Decision Support & Reference
OrthoPlan is an AI-enhanced digital templating software for orthopedic surgery that streamlines surgical planning and offers automated bone segmentation and implant positioning.

See all Surgical AI tools →

More from Procept Biorobotics

HYDROS Robotic System
Procept Biorobotics
Surgical AI
The HYDROS Robotic System by Procept Biorobotics is an AI-powered surgical robot for Aquablation therapy, treating benign prostatic hyperplasia (BPH) with advanced image guidance and robotic precision to preserve sexual function and continence.
Not disclosed
HYDROS TRUS Probe
Procept Biorobotics
Radiology & Imaging AI
The HYDROS Robotic System is the next-generation, AI-powered platform for Aquablation therapy, offering a minimally invasive, robotic-assisted waterjet treatment for benign prostatic hyperplasia (BPH) that aims to provide durable symptom relief while preserving sexual function and continence.
Not publicly available

View company profile →

Suggest an Edit → | Last Verified: 2026-04-20 | First Added: 2026-04-20
AI Tool Finder
AI-powered search. Results may not be comprehensive.