HYDROS TRUS Probe

by Procept Biorobotics  · Based in United States → — Redefining choices in men's health.
Radiology Urology
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Not publicly available
Regulatory Status Disclosed

Overview

The HYDROS Robotic System, which includes the HYDROS TRUS Probe, is an advanced, AI-powered platform designed for Aquablation therapy. This system provides a minimally invasive, robotic-assisted waterjet treatment for benign prostatic hyperplasia (BPH). It integrates AI-powered treatment planning with FirstAssist AI™, advanced image guidance through next-generation ultrasound imaging, digital cystoscopy, and dual high-definition touchscreens, and precise robotic resection using a heat-free waterjet. The HYDROS TRUS Probe itself is a reusable biplane transrectal ultrasound probe that works in conjunction with the HYDROS Robotic System and HYDROS Handpiece to provide essential ultrasound imaging during the Aquablation procedure. The system is engineered to enhance efficiency, improve surgeon and staff experience, and deliver accurate and consistent treatment plans for patients suffering from lower urinary tract symptoms (LUTS) due to BPH, while aiming to preserve sexual function and continence.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered treatment planning (FirstAssist AIu2122)
  • Advanced image guidance (next-generation ultrasound, digital cystoscopy, dual HD touchscreens)
  • Robotic-assisted heat-free waterjet resection
  • Streamlined workflow
  • Real-time ultrasound imaging
  • Personalized and anatomy-specific therapy
  • Robotic precision and reproducibility
  • Treatment for benign prostatic hyperplasia (BPH)

Use Cases

  • Treatment of benign prostatic hyperplasia (BPH)
  • Resection and removal of prostate tissue in males with LUTS due to BPH
  • Minimally invasive urologic surgery

Details

Category Radiology & Imaging AI, Surgical AI
Pricing Not publicly available — N/A
DeploymentOn-premise (medical device in clinical setting)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The HYDROS Robotic System, including the HYDROS TRUS Probe, received FDA 510(k) clearance (K251082 on Oct 10, 2025, and K240200 on Aug 20, 2024) 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 Radiology, Urology

What the Web Says

The HYDROS TRUS Probe is a component of the HYDROS Robotic System, an AI-powered platform for Aquablation therapy used to treat benign prostatic hyperplasia (BPH). Physicians highlight its role in providing real-time ultrasound imaging for precise surgical planning and execution, aiming to improve patient outcomes by minimizing side effects like erectile and ejaculatory dysfunction. The system is designed to be user-friendly, with AI assistance for landmark identification and a disposable probe for convenience.

Overall: Positive

Strengths

  • Precise, image-guided treatment with real-time ultrasound mapping.
  • AI-powered assistance for improved accuracy in anatomical landmark identification.
  • Heat-free resection minimizes bleeding and enhances recovery.
  • Preserves continence and sexual health with low rates of erectile and ejaculatory dysfunction.
  • Streamlined and predictable surgical experience, accommodating various prostate sizes and shapes.
  • Disposable probe for convenience and reduced reprocessing issues.

Limitations

  • Potential for fluid ingress into probes if reprocessed incorrectly.
  • Occasional imaging glitches leading to aborted procedures.
  • Some users on Reddit report issues with other Hydros probes (not specifically TRUS) regarding accuracy, calibration, and overall system reliability, though these may not directly apply to the medical device.
  • Limited long-term follow-up data in some studies.
  • Requires understanding of transrectal ultrasonography and treatment planning for optimal use.
  • Potential perioperative risks, as with any surgical procedure.

Based on reviews from: YouTube (Steve Bell - Medtech Mavericks), accessdata.fda.gov (MAUDE Adverse Event Report), YouTube (Dr. Helfand Testimonial), Reef2Reef (Hydros sensor/probe quality), PMC (A Narrative Review of Robotic Aquablation in Benign Prostatic Hyperplasia Care: Where We Are Now), Reddit (r/ReefTank - Got a hydros, hate it), MedTech Dive, accessdata.fda.gov (FDA 510(k) clearance documents), YouTube (First Full Aquablation Case with NEW HYDROS AI Platform), Reddit (r/scubaGear - Anyone else struggling with the Hydros Pro's buoyancy and trim?), Reef2Reef (Hydros controller), Reef2Reef (Neptune Apex and CoralVue Hydros: Personal Opinion and Experience), Reddit (For people running a Hydros system. What sensor do you recommend for ATO?), Reddit (For Our Fellas with BPH, I had Aquablation Done 8 Days Ago. Ask Me Anything.), Urology Times (Expert gives advice on implementing Aquablation with the HYDROS Robotic System), Central Ohio Urology Group

Last updated: 2026-07-19

Ratings & Reviews

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Press & Coverage

Innolitics
2025 Year in Review: Cardiology AI/ML SaMD 510(k) Clearances - Innolitics
This article provides a comprehensive analysis of 2025 cardiology AI/ML clearances, market trends, capital events, and regulatory insights, mentioning the HYDROS Robotic System, HYDROS Handpiece, and HYDROS TRUS Probe from Procept BioRobotics with a 510(k) clearance date of October 10, 2025.
2026-01
FDA
510(k) Premarket Notification - FDA
This FDA 510(k) Premarket Notification details the HYDROS Robotic System, HYDROS Handpiece, and HYDROS TRUS Probe from Procept BioRobotics, listing the applicant and correspondent information.
2026-07
accessdata.fda.gov
August 20, 2024 Procept BioRobotics Sara Muddell Sr. Director, Global Regulatory Affairs 150 Baytech Drive San Jose, California - accessdata.fda.gov
This FDA document is a 510(k) summary for the HYDROS Robotic System, including the HYDROS TRUS Probe, outlining its intended use for prostate tissue removal in males with LUTS due to BPH.
2024-08
accessdata.fda.gov
October 10, 2025 Procept BioRobotics Bijesh Chandran Senior Vice President, Regulatory Affairs and Quality Assurance 150 Baytech - accessdata.fda.gov
This FDA 510(k) summary, dated September 12, 2025, details the HYDROS Robotic System, HYDROS TRUS Probe, and HYDROS Handpiece, classifying it as a Class II medical device for fluid jet prostate tissue removal.
2025-10
Innolitics
FDA 510(k) Search and Medical Device Explorer | Innolitics
Innolitics' FDA 510(k) Search and Medical Device Explorer lists the HYDROS TRUS Probe (HU1000) by Procept Biorobotics with a clearance date of July 9, 2026.
2026-07
FDA.report
Astra Tee A9009-01 ASTRA TEE Transesophageal Probe Reprocessor GUDID Device - FDA.report
This FDA.report entry, while primarily about a transesophageal probe reprocessor, includes a mention of the HYDROS TRUS Probe by PROCEPT BioRobotics Corporation with a GUDID publication date of September 6, 2024.
2024-09
Ovid
FDA-approved artificial intelligence and machine... : Surgery - Ovid
This peer-reviewed article discusses FDA-approved AI/ML-enabled medical devices in general surgery, listing the HYDROS Robotic System, HYDROS TRUS Probe, and HYDROS Handpiece by Procept BioRobotics as a fluid jet removal system with an approval date of August 20, 2024.
2024-08

Videos

Product demos, reviews, and walkthroughs for HYDROS TRUS Probe.

View all on YouTube

Frequently Asked Questions

AI integration can significantly improve prostate cancer detection and risk stratification by analyzing transrectal ultrasound (TRUS) images, potentially offering a more precise and consistent diagnostic tool. It can also assist in pinpointing suspicious areas for biopsy, thereby enhancing diagnostic accuracy and potentially reducing the need for more resource-intensive imaging modalities like multiparametric MRI.
FDA approval for AI-powered medical devices involves rigorous evaluation through pathways like premarket clearance, De Novo classification, or premarket approval. Manufacturers must submit predetermined change control plans for software updates, demonstrate data lineage, conduct bias analysis, and outline human-AI workflows. Cybersecurity measures and robust post-market performance monitoring are also critical for ensuring ongoing safety and effectiveness.
Current alternatives include multiparametric MRI (mpMRI), which is often considered a gold standard for prostate cancer diagnosis and can guide targeted biopsies. Traditional TRUS-guided systematic biopsies are also widely used. Other diagnostic approaches involve prostate-specific antigen (PSA) tests, digital rectal exams, and various ultrasound-based techniques.
The cost of integrating AI into medical imaging and diagnostic software can range significantly, from approximately $300,000 to over $1.5 million for comprehensive platforms. Custom deep learning solutions alone may cost $200,000 to $500,000+. Additionally, regulatory pathways add substantial validation expenses, and ongoing operational costs include inference compute power and continuous monitoring, which can be thousands of dollars monthly.
Limitations of AI in TRUS include its current inability to predict the full five-tier ISUP Gleason Grade stratification and potential for bias stemming from insufficient, poor-quality, or unrepresentative training data. AI models may also struggle to generalize to real-world clinical settings or outlier cases, and their 'black box' nature can make it difficult for physicians to understand the reasoning behind a diagnosis, necessitating human oversight.
Training AI for a TRUS probe requires large, high-quality, and diverse datasets, often including 3D volumes reconstructed from 2D B-mode images, and potentially fusion with MRI data. Challenges include ensuring the data is representative across varied demographics, imaging procedures, and equipment types, as well as mitigating labeling and technical errors within vast datasets.
AI integration is designed to augment, rather than replace, the physician's role by providing enhanced analytical capabilities and decision support. Physicians will continue to be essential as the final arbiters of diagnosis and treatment, overseeing AI outputs, managing human-AI workflows, and ensuring that patient care remains personalized and ethical.

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More from Procept Biorobotics

HYDROS Handpiece
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The HYDROS Handpiece is a single-use component of Procept Biorobotics' HYDROS Robotic System, an AI-powered surgical platform for Aquablation therapy, treating benign prostatic hyperplasia (BPH) with precision and heat-free waterjet resection.
HYDROS Robotic System
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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

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Suggest an Edit → | Last Verified: 2026-04-19 | First Added: 2026-04-19
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