Clarius Prostate AI

by Clarius Mobile Health  · Based in Canada → — AI-Powered Prostate Volume Measurement for Handheld Ultrasound
Oncology Radiology Urology
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Requires purchase of a clarius handheld ultrasound scanner and an annual clarius membership.
Regulatory Status Disclosed

Overview

Clarius Prostate AI is an innovative artificial intelligence application developed by Clarius Mobile Health, designed to revolutionize prostate volume measurement during handheld ultrasound examinations. Integrated seamlessly within the Clarius App on a smartphone or tablet, this semi-automatic tool significantly reduces the time required for prostate volume measurements from minutes to mere seconds. It automatically highlights the prostate gland and places calipers for measurement, which clinicians can then fine-tune manually for precision. Beyond volume measurement, Clarius Prostate AI also calculates Prostate-Specific Antigen (PSA) density by incorporating the patient’s PSA level, aiding in the earlier and more informed detection of prostate cancer and assessment of conditions like Benign Prostatic Hyperplasia (BPH). The tool is available for use with Clarius handheld ultrasound scanners, specifically the curvilinear C3 HD3 for transabdominal ultrasound and the endocavitary EC7 HD3, which are customized for urology exams.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered prostate volume measurement
  • Reduces measurement time to seconds
  • Calculates PSA density
  • Semi-automatic caliper placement with manual fine-tuning
  • Integrates with Clarius handheld ultrasound scanners (C3 HD3, EC7 HD3)
  • Activated within the Clarius App on smartphone or tablet
  • Aids in assessing urologic conditions like BPH and prostate cancer
  • Part of the broader Clarius AI portfolio
  • Real-time image processing
  • High-definition wireless ultrasound

Use Cases

  • Prostate volume measurement during ultrasound exams
  • Calculation of PSA density for risk assessment
  • Earlier identification of high-risk prostate cancer patients
  • Assessment of Benign Prostatic Hyperplasia (BPH)
  • Streamlining urologic diagnostics
  • Enhancing clinical efficiency in urology and primary care

What Physicians Need to Know

Key Capabilities
Semi-automatic calculation of prostate volume and PSA density during ultrasound exams. The tool automatically highlights the prostate gland and places calipers, which can be manually fine-tuned for precision. It significantly reduces measurement time from minutes to seconds.
Clinical Utility
Aids in assessing urologic conditions like Benign Prostatic Hyperplasia (BPH) and prostate cancer, supporting earlier and more informed detection. It empowers a broader range of physicians, including primary care, to utilize ultrasound for identifying high-risk prostate cancer patients, potentially reducing specialist referrals and improving clinical efficiency.
Integration Options
Integrated within the Clarius App, compatible with iOS and Android smartphones and tablets, and works with Clarius handheld ultrasound scanners (C3 HD3 and EC7 HD3). The Clarius ecosystem supports third-party AI integrations via an open-source platform and SDK, and includes features like specialized imaging presets, built-in patient reports, integrated billing codes, and Clarius Cloud for unlimited storage and DICOM export.
Compliance Status
FDA 510(k) cleared. It is intended as an assistive tool to inform clinical management and not to replace clinical decision-making, with the clinician retaining ultimate responsibility for measurements. The tool is indicated for use in adult male patients only.
Pricing Model
Available through a Clarius Membership or a One-Time License. The Clarius Membership offers advanced features, specialist software, image storage, and educational content. Specific pricing for a 'Clarius Membership - One Time' is $2,500.00 USD, with monthly payment options also available for other AI tools. Special pricing may be offered to members of Specialty Networks and Afaxys.
User Experience
Designed for ease of use, activated with a tap in the Clarius App. Its semi-automatic nature with manual fine-tuning options streamlines workflow. Surveys indicate 95% of clinicians believe AI-powered measurements save time and allow for more patient consultations.
Support Quality
Clarius Membership includes a 1-hour virtual in-service, monthly online training, and in-app Clarius Classroom Videos. An optional Clarius Care Extended Warranty provides prompt loaner/replacement scanners and expedited shipping. Clarius also engages in global medical tradeshows and clinical webinars.
Implementation Complexity
Low complexity as it integrates into the existing Clarius App and works with Clarius handheld wireless ultrasound scanners. It is not a standalone software and requires the Clarius ultrasound system.
Evidence Base
Backed by FDA 510(k) clearance and clinical validation studies. Automated prostate volume measurements were found to be non-inferior to human experts with statistically significant results (p-value of 1.146e-5). Bland-Altman plots showed strong agreement and high accuracy (95%) in view prediction.
Physician Tip

Clarius Prostate AI offers a significant time-saving advantage for prostate volume measurements and PSA density calculations, making it a valuable tool for both urologists and primary care physicians. While the AI provides automated measurements, always remember to manually review and fine-tune the calipers for optimal precision and to exercise your clinical judgment, as the AI is an assistive tool, not a replacement for medical expertise. Its integration with portable handheld scanners enhances flexibility for point-of-care assessments. Consider leveraging the educational resources provided by Clarius to maximize proficiency with the tool.

Clarius Prostate AI is deeply integrated into the Clarius App and ecosystem, requiring a Clarius handheld ultrasound scanner. The open platform and SDK suggest potential for future integrations with other AI solutions and healthcare IT systems, offering flexibility for clinics looking to expand their digital health tools. The inclusion of built-in patient reports and integrated billing codes streamlines administrative workflows.

Details

Category Oncology AI, Radiology & Imaging AI
Pricing Requires purchase of a clarius handheld ultrasound scanner and an annual clarius membership.
  • Scanner prices vary (e.g., EC7 HD3 for urology starts at $5,990 USD); Annual Clarius Membership is $595 USD, which unlocks AI tools and advanced features
DeploymentMobile app-based, integrated with Clarius handheld ultrasound scanners.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

Clarius Prostate AI received 510(k) clearance (K243853) from the U.S. Food and Drug Administration (FDA) on April 16, 2025. It is intended for semi-automatic measurements of prostate volume on ultrasound data acquired by Clarius Ultrasound Scanners (C3 HD3 and EC7 HD3) and calculates PSA density.
Integrations
EHR Not specified
Specialties Oncology, Radiology, Urology

What the Web Says

Clarius Prostate AI is an FDA-cleared artificial intelligence application designed to quickly and accurately measure prostate volume during handheld ultrasound examinations. It integrates with Clarius handheld ultrasound scanners and can calculate PSA density, aiming to improve clinical efficiency and facilitate earlier identification of high-risk prostate cancer patients, potentially reducing the need for specialist referrals. The tool is activated within the Clarius App on a smartphone or tablet, automatically highlighting the prostate and placing calipers for measurement, which can then be manually fine-tuned.

Overall: Positive

Strengths

  • Reduces prostate volume measurement time from minutes to seconds, enhancing clinical efficiency.
  • Enables primary care physicians to identify high-risk prostate cancer patients earlier.
  • Calculates PSA density by incorporating patient PSA levels and prostate volume.
  • Offers high accuracy in prostate volume measurements compared to human experts.
  • User-friendly interface with automated features and manual fine-tuning options.
  • Wireless and portable, connecting to iOS and Android devices, making it convenient for various clinical settings.

Limitations

  • Requires Clarius handheld ultrasound scanners, limiting use to their ecosystem.
  • Some users of Clarius devices (not specific to Prostate AI) have reported occasional poor wireless connection and slower frame rates, particularly with Android devices.
  • Initial connection time for wireless devices can take a moment, requiring planning.
  • The app is an assistive tool and not intended to replace clinical decision-making; the clinician retains ultimate responsibility for measurements.
  • No specific reviews from G2 or Capterra were found.
  • Limited independent tech reviews specifically for Clarius Prostate AI were found; most information comes from company press releases and medical news outlets.

Based on reviews from: Urology Times, PR Newswire, AuntMinnie, FDA, PubMed, ResearchGate, Investors Hangout, Reddit, YouTube, Mr Feras Al Jaafari (website)

Last updated: 2026-07-18

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Press & Coverage

PR Newswire
FDA Clears New Clarius Prostate AI To Help Physicians Assess and Diagnose Common Urologic Conditions in Minutes
Clarius Mobile Health announced FDA clearance for Clarius Prostate AI, a semi-automatic tool that quickly and accurately calculates prostate volume during ultrasound exams, aiming to save physicians time and enable them to see more patients.
2025-04
Urology Times
FDA clears AI-powered application for measuring prostate volume | Urology Times
Clarius Mobile Health's Clarius Prostate AI, an AI application for measuring prostate volume during handheld ultrasound, has received FDA clearance. The app also calculates PSA density and is being demonstrated at the American Urological Association Annual Meeting.
2025-04
Applied Radiology
FDA Clears AI-Powered Prostate Volume Measurement for Handheld Ultrasound
Clarius Prostate AI, an AI application for handheld ultrasound that enables rapid calculation of prostate volume, has received 510(k) clearance from the FDA. It is reportedly the first AI-enabled prostate measurement tool to garner FDA clearance for use with handheld ultrasound.
2025-04
Investors Hangout
Clarius Mobile Health Launches Groundbreaking Prostate AI Tool - Investors Hangout
Clarius Mobile Health has launched Clarius Prostate AI, an FDA-cleared tool that quickly and accurately calculates prostate volume, significantly reducing measurement time for diagnosing conditions like BPH and prostate cancer.
2025-04
Urology Times
Regulatory recap: FDA approvals in urology from the first half of 2025
This article provides a recap of FDA approvals in urology during the first half of 2025, including the clearance of Clarius Prostate AI on April 25, 2025, for measuring prostate volume during handheld ultrasound exams.
2025-07
AuntMinnie
Clarius launches Clarius Prostate AI - AuntMinnie
Clarius Mobile Health is launching Clarius Prostate AI, a semiautomatic tool for calculating prostate volume during ultrasound exams, which has secured 501(k) clearance from the U.S. Food and Drug Administration (FDA).
2025-04
Urology Times
FDA updates in urology: April 2025
This article summarizes key FDA updates in urology for April 2025, highlighting the clearance of Clarius Prostate AI on April 25, 2025, for advanced prostate volume measurement during handheld ultrasound exams.
2025-05
PR Newswire
Clarius Mobile Health Announces Historic 2025: Achieves Profitability, Double-Digit Growth, and New FDA Clearances for Ultrasound AI - PR Newswire
Clarius Mobile Health announced its 2025 achievements, including profitability, growth, and new FDA clearances for AI models, specifically mentioning Clarius Prostate AI for automatically identifying the prostate and performing measurements.
2025-12

Videos

Product demos, reviews, and walkthroughs for Clarius Prostate AI.

View all on YouTube

Frequently Asked Questions

Clarius Prostate AI integrates seamlessly into the Clarius App on a smartphone or tablet, allowing activation with a simple tap during an ultrasound exam. It automatically highlights the prostate and places calipers for volume measurement, which clinicians can manually fine-tune for precision, significantly reducing the time compared to manual methods. The intuitive interface and semi-automatic nature suggest a minimal learning curve for physicians already familiar with Clarius ultrasound systems.
Clarius Prostate AI has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), making it an FDA-cleared AI-powered tool for real-time prostate volume and PSA density measurement. While specific HIPAA compliance details for data handling are not explicitly detailed in the search results, Clarius offers a cloud-based system for exam management and storage, which typically adheres to medical data privacy regulations.
Clarius Prostate AI offers a significant advantage over traditional manual ultrasound methods by automating prostate volume measurement, reducing the process from minutes to seconds. While other AI tools exist for prostate pathology or cancer localization, Clarius Prostate AI specifically focuses on real-time, semi-automatic prostate volume and PSA density calculation during handheld ultrasound exams.
Clarius Prostate AI is available through a Clarius Membership or a One-Time License. A Clarius Membership includes advanced features, specialized software, AI-powered tools, and unlimited storage. A 'Clarius Membership - One Time' is listed at $2,500.00 USD, with international pricing potentially varying.
Clarius Prostate AI is intended as an assistive tool to inform clinical management and does not replace clinical decision-making; the clinician retains ultimate responsibility for measurements and judgment. Clinical validation studies have demonstrated its performance to be non-inferior to experienced clinicians for prostate volume measurement. While general algorithmic bias is a concern in medical AI, Clarius states that modifications to its AI algorithm are made in accordance with a Predetermined Change Control Plan.
Clarius Prostate AI is specifically designed for use with Clarius handheld ultrasound scanners that are customized for urology exams. These include the curvilinear C3 HD3 for transabdominal ultrasound and the endocavitary EC7 HD3 for transrectal imaging. It is activated within the Clarius App on a smartphone or tablet connected to these specific scanners.
Clarius Prostate AI aids in earlier, more informed detection of prostate cancer by quickly and accurately calculating prostate volume and then using that volume to determine PSA density when a patient's PSA value is entered. This streamlined process enables physicians, including primary care, to identify high-risk patients sooner without always relying on specialist referrals.

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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18
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