Clarius Prostate AI

by Clarius Mobile Health  · Based in Canada → — Smarter Insights. Faster Care. High-resolution wireless ultrasound that’s intuitive and built for the way you practice.
Oncology Radiology Urology
Website
Claim this tool
Is this the maker? Claim the company →

Starts at $3,795 for scanners, with an optional clarius essentials membership at $695/year or a one-time purchase of $2,500.
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
Clarius Prostate AI automatically identifies the prostate, measures its volume, and calculates PSA density. It highlights the prostate gland with a masking overlay and places calipers for measurement, which can be manually adjusted for precision. The tool is designed to reduce the time it takes to measure prostate volume from minutes to seconds. It is available with Clarius handheld ultrasound scanners customized for urology exams, including the curvilinear C3 HD3 for transabdominal ultrasound and the endocavitary EC7 HD3 for transrectal imaging.
Clinical Utility
Clarius Prostate AI assists in assessing urologic conditions such as Benign Prostatic Hyperplasia (BPH) and prostate cancer by providing quick and accurate prostate volume measurements and PSA density calculations. It aims to enable primary care physicians to identify high-risk prostate cancer patients earlier, potentially reducing the reliance on specialist referrals. The tool is intended to improve efficiency and consistency in prostate imaging.
Integration Options
Clarius Prostate AI is integrated into the Clarius App, which runs on compatible smartphones and tablets. It is part of a larger suite of AI models within the Clarius ecosystem, including Bladder AI and Voice Controls. The measurements are transferred to the Clarius Cloud.
Compliance Status
Clarius Prostate AI has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). It is also CE-marked, making it available in the European Union and the United Kingdom.
Pricing Model
Clarius Prostate AI is available with a Clarius membership or a one-time license. Clarius scanners do not require a membership or subscription for core imaging, but a Clarius Cloud membership is optional and adds features like AI models. Pricing for Clarius products varies by region and distributor.
User Experience
The tool is activated with a tap in the Clarius App. It automatically highlights the prostate and places calipers, which can be manually adjusted for precision. The app calculates prostate volume and PSA density, with measurements transferred to the Clarius Cloud. Users have noted its user-friendly interface and educational value.
Support Quality
Clarius offers support for its products, including assistance with product questions and scanner support.
Implementation Complexity
The AI models run directly on compatible smartphones and tablets, enabling supported capabilities without an internet connection during scanning. The tool is designed to be simple to use during a prostate exam.
Evidence Base
Clarius Prostate AI is an FDA-cleared and CE-marked tool. Clarius has a track record of developing and clinically validating AI models. Internal surveys by Clarius indicate that 95% of clinicians believe AI-powered measurements would save them time and allow them to see more patients.
Physician Tip

Clarius Prostate AI can significantly reduce the time required for prostate volume measurements, enhancing clinical efficiency. The ability to manually adjust calipers after automatic placement ensures accuracy and physician control. Integrating patient PSA levels into the app for automatic PSA density calculation streamlines the assessment process. This tool can be particularly beneficial for primary care physicians to facilitate earlier identification of high-risk prostate cancer patients.

Clarius Prostate AI operates within the Clarius App on iOS and Android devices, integrating seamlessly with Clarius handheld ultrasound scanners. It is part of a broader suite of Clarius AI tools, including Bladder AI and Voice Controls, which can further enhance workflow. Measurements and images are saved and transferred to the Clarius Cloud, facilitating data management and reporting.

Details

Category Oncology AI, Radiology & Imaging AI
Pricing Starts at $3,795 for scanners, with an optional clarius essentials membership at $695/year or a one-time purchase of $2,500.
DeploymentMobile app (iOS and Android) connected to wireless handheld ultrasound scanners.
Mobile AppYes
Data ExportUnknown
TrainingUnknown
Compliance
BAA Available Yes AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Cleared AI-estimated
GDPR Yes AI-estimated
Integrations
EHR Not specified
Specialties Oncology, Radiology, Urology

Support & Reliability

Training ProvidedUnknown

What the Web Says

Clarius Prostate AI is an FDA-cleared, AI-powered tool integrated into Clarius handheld ultrasound scanners that aims to streamline prostate volume measurement and PSA density calculation. It is designed to assist clinicians, including primary care physicians and urologists, in quickly assessing prostate morphology and volume. The AI automatically highlights the prostate and places calipers for measurement, which can then be manually adjusted for precision. This technology is intended to improve efficiency and potentially enable earlier identification of high-risk prostate cancer patients.

Overall: Positive

Strengths

  • Reduces prostate volume measurement time from minutes to seconds, enhancing clinical efficiency.
  • Automatically identifies the prostate and places calipers for measurement, with options for manual fine-tuning.
  • Calculates PSA density by incorporating patient PSA levels and prostate volume.
  • Enables earlier and more informed decision-making for patient care, potentially reducing reliance on specialist referrals.
  • Offers a portable, non-invasive, and clinically accurate method for prostate assessments, especially for larger prostates.
  • Helpful for clinicians who are early in their ultrasound experience by guiding anatomy recognition and visualization.

Limitations

  • Some users have reported issues with wireless connectivity and low bandwidth, potentially affecting frame rate.
  • Reliability for prostate gland volume (PGV) measurements was found to be moderate in comparison to another handheld ultrasound device in one study.
  • AI tools, including those for prostate cancer detection, require careful interpretation and understanding of factual parameters to avoid misinterpretation.
  • The impact of AI in prostate imaging on reimbursement and guideline support is still developing.
  • Prostate AI is available only in select regions.

Based on reviews from: nih.gov, innolitics.com, youtube.com, researchgate.net, clarius.com, urologytimes.com, mensreproductivehealth.com, diagnosticimaging.com, signifyresearch.net, prnewswire.com, reddit.com

Last updated: 2026-10-29

Ratings & Reviews

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

Rate Clarius Prostate AI

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

Press & Coverage

clarius.com
FDA Clears New Clarius Prostate AI To Help Physicians Assess and Diagnose Common Urologic Conditions in Minutes
Clarius Mobile Health announced that its Clarius Prostate AI, an FDA-cleared semi-automatic tool, can quickly and accurately calculate prostate volume during ultrasound exams, aiding in the assessment of urologic conditions like BPH and prostate cancer. This marks the first FDA-cleared AI-powered prostate measurement tool on a handheld ultrasound scanner.
2025-04
diagnosticimaging.com
FDA Clears AI-Powered Prostate Volume Measurement for Handheld Ultrasound
The FDA has granted 510(k) clearance for Clarius Prostate AI, an AI application for handheld ultrasound that enables rapid calculation of prostate volume and PSA density. This tool is showcased at the American Urological Association (AUA) conference and aims to save clinicians time.
2025-04
clarius.com
Assess and Diagnose Urologic Conditions Quickly with New Clarius Prostate AI
Clarius has introduced Prostate AI, an FDA-cleared AI-powered prostate measurement tool for handheld ultrasound scanners, which quickly and accurately calculates prostate volume. This innovation aims to save time for urologists, as 95% of surveyed clinicians believe AI-powered measurements would enhance efficiency.
2025-04
auntminnie.com
Clarius Mobile Health Launches Prostate AI
Clarius Mobile Health has launched Clarius Prostate AI, a semi-automatic tool that calculates prostate volume during ultrasound exams, which has received 510(k) clearance from the FDA. The tool automatically highlights the prostate gland and places calipers for measurement, also calculating PSA density.
2025-04
firstwordhealthtech.com
FDA Clears New Clarius Prostate AI To Help Physicians Assess and Diagnose Common Urologic Conditions in Minutes
Clarius Mobile Health's Clarius Prostate AI has received FDA clearance, offering a semi-automatic tool to quickly and accurately calculate prostate volume during ultrasound exams. This development aims to assist physicians in assessing and diagnosing common urologic conditions more efficiently.
2025-04
fda.gov
Clarius Prostate AI
The FDA's 510(k) Premarket Notification for Clarius Prostate AI from Clarius Mobile Health Corp. was cleared on April 16, 2025, under regulation number 892.2050, classifying it as an image processing device.
2025-04
clarius.com
Clarius Mobile Health Announces Record Year for 2025 Driven by Profitability and 20% Growth
Clarius Mobile Health reported a record year in 2025, achieving profitability and 20% growth, partly due to the introduction of two new FDA-cleared AI models, including Clarius Prostate AI. Clarius Prostate AI automatically identifies the prostate and performs measurements for urological assessments.
2025-12
mensreproductivehealth.com
Ultrasound innovation in urology: What's new in 2025?
In April 2025, Clarius Prostate AI was introduced as the first FDA-cleared AI tool specifically for prostate ultrasound, capable of automatically recognizing, outlining, and calculating prostate volume, as well as computing PSA density.
2026-01

Videos

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

View all on YouTube

Frequently Asked Questions

Clarius Prostate AI is an FDA-cleared, semi-automatic tool that quickly and accurately calculates prostate volume during an ultrasound exam. It automatically highlights the prostate gland and places calipers to measure volume, which clinicians can fine-tune. The app also calculates PSA density using the entered PSA value and measured volume, supporting earlier and more informed detection of prostate cancer.
Clarius Prostate AI is the first FDA-cleared AI-powered prostate measurement tool on a handheld ultrasound scanner. It has also received CE Mark approval, making it available in the European Union and the United Kingdom. This clearance indicates that the device has met the necessary safety and effectiveness standards for medical use.
While Clarius Prostate AI focuses on prostate volume measurement and PSA density calculation using handheld ultrasound, other AI tools exist for prostate cancer. For example, ProCUSNet is an AI tool that analyzes ultrasound images to localize areas of cancer and has shown improved detection rates for high-grade prostate cancers. Additionally, AI models for prostate cancer detection on MRI are also available. Unfold AI integrates patient data from imaging, biopsies, and pathology to create personalized cancer maps for treatment planning.
Clarius Prostate AI is available with a Clarius Membership or a One-Time License. This includes specialized imaging presets, built-in patient reports, and integrated billing codes to streamline workflow. While Clarius scanners do not require a membership for core imaging, a Clarius Cloud membership is optional and adds features like AI models. Pricing varies by region and distributor, and special pricing may be available for members of Specialty Networks.
Clarius Prostate AI is a semi-automatic tool for prostate volume measurement and PSA density calculation. While it significantly reduces the time for these measurements, clinicians can still manually fine-tune the calipers for precision. The effectiveness of AI models can depend on the quality and diversity of training data, and there's a concern about potential over-reliance on AI diminishing clinical judgment. It's important to note that Clarius Prostate AI is designed to assist in early detection and assessment, not to provide a definitive cancer diagnosis on its own.

Related Tools

SOPHiA DDM
SOPHiA GENETICS
Oncology AI
SOPHiA DDM™ is an AI-driven and cloud-powered platform that helps clinicians generate real-time, actionable insights for patients with cancer and rare disorders by analyzing complex genomic, radiomic, and multimodal data.
Paid
CerviCARE AI
NTL Healthcare
OB/GYN AI
CerviCARE AI is an AI-powered cervical cancer screening system that analyzes smartphone images of the cervix to predict findings, aiming for early detection.
Lumonus AI
Lumonus
Clinical Decision Support & Reference
Lumonus AI is an AI-powered software that assists healthcare providers with prescriptions, dosing, and treatment for cancer patients, with a module (Sigma) that suggests treatment protocols based on prior plans for similar patients.
DeepBio DeepDx® Prostate
DeepBio
Oncology AI
DeepDx® Prostate leverages deep learning to standardize prostate cancer diagnostics by detecting abnormalities in digital slides with high precision, providing automated Gleason grading, tumor quantification, and tumor length measurements.
AIRA Matrix AI Solutions
AIRA Matrix
Lab & Diagnostics
AIRA Matrix offers AI solutions to improve efficiency and diagnostic accuracy in pathology lab workflows, primarily for prostate and breast cancer, with services like DPaaS and predictive toxicology.
Surgical Reality Viewer
Surgical Reality
Oncology AI
Surgical Reality offers CE- and FDA-certified AI-powered 3D medical imaging and surgical planning software that transforms CT scans into patient-specific 3D models for thoracic surgery, enhancing precision in complex lung procedures.

See all Oncology AI tools →

More from Clarius Mobile Health

Clarius AI
Clarius
Cardiology AI
Clarius AI is a suite of artificial intelligence features integrated into Clarius Mobile Health's handheld ultrasound scanners and app, designed to enhance image quality, automate measurements, and provide real-time guidance for clinicians across various specialties.
Clarius Bladder AI
Clarius Mobile Health
Clinical Decision Support & Reference
Clarius Bladder AI is a non-invasive, AI-powered tool that automatically and accurately measures bladder volume in seconds using Clarius HD3 wireless handheld ultrasound scanners, providing real-time feedback to clinicians.
Clarius bladder ai is included with the advanced primary / critical care package, which is part of the clarius membership. clarius hd3 scanners start at $2,995 usd with an annual membership of $595 usd, or can be purchased as a one-time payment starting at $4,900 usd. the membership is essential for accessing advanced software features, including ai tools and cloud management.
Clarius Ejection Fraction AI
Clarius Mobile Health Corp.
Cardiology AI
Clarius Ejection Fraction AI is an AI-powered ultrasound tool for automated left ventricular ejection fraction calculation, integrated into the Clarius Ultrasound App for real-time cardiac assessments.
Contact for pricing
Clarius Median Nerve AI
Clarius Mobile Health
Neurology AI
Clarius Median Nerve AI is an FDA-cleared, AI-powered tool within the Clarius Ultrasound App that assists clinicians in real-time localization and measurement of the median nerve for Carpal Tunnel Syndrome assessments using handheld ultrasound scanners.
Starts at $3,795 or $5,395 for the scanner, with optional clarius essentials at $695/year or a one-time $2,500.

View company profile →

Suggest an Edit → | Report an issue | Last Verified: 2026-04-18 | First Added: 2026-04-18
AI Tool Finder
AI-powered search. Results may not be comprehensive.