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Clarius Bladder AI

by Clarius Mobile Health · Based in Canada → — AI-powered wireless ultrasound for accurate, real-time bladder volume measurement.

Emergency Medicine Radiology Urology

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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.

Regulatory Status Disclosed

Overview

Clarius Bladder AI is an automated, non-invasive software application designed to streamline bladder volume measurements using Clarius wireless handheld ultrasound scanners, such as the Clarius C3 HD3.

Target Users and Care Settings:

Specialties: Urology, emergency medicine, acute care, primary care, nursing, and pelvic floor physical therapy.
Care Settings: Emergency departments, outpatient clinics, long-term care facilities, and rehabilitation centers.

Workflow Integration and Capabilities:

Automated Calculations: The tool automatically identifies, outlines, and highlights the bladder boundaries on live or saved ultrasound images, calculating total bladder volume in seconds without requiring manual caliper placement.
Clinical Utility: It helps clinicians quickly assess urinary retention, evaluate bladder emptying, and measure post-void residual (PVR) volume to assist in clinical decisions regarding catheterization or further diagnostic investigation.
Versatile Hardware: Because the software runs on the ultraportable Clarius scanner, providers can perform rapid bladder assessments at the point of care alongside standard abdominal, pelvic, or thoracic imaging.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

Automatic bladder volume measurement
Real-time feedback to clinicians
Non-invasive bladder scanning
AI-powered image optimization
Integration with Clarius HD3 wireless handheld ultrasound scanners
Intuitive mobile app interface (iOS and Android)
Automated caliper placement for measurements
On-screen volume calculation display
Ability to save images and measurements to patient files
Versatile for general ultrasound exams beyond bladder scanning

Use Cases

Monitoring urinary retention
Assessing bladder emptying in patients with neurogenic bladder or urinary tract obstruction
Measuring post-void residual urine
Evaluating for bladder and urethral stones
Assessing hydronephrosis
Management and evaluation of urinary incontinence

What Physicians Need to Know

Evidence Base

Clarius Bladder AI is a non-invasive tool for automatic bladder volume measurement, particularly useful for monitoring urinary retention and assessing bladder emptying in patients with neurogenic bladder or urinary tract obstruction. It leverages machine learning algorithms to identify the bladder region, reduce artifacts, and enhance image quality, operator consistency, and real-time diagnostic accuracy. A 2023 study supports the feasibility of bladder ultrasound in clinical practice for reducing inappropriate catheter use, patient risks, and healthcare costs.

Clinical Validation Studies

The Clarius Bladder AI has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). A prospective, non-inferiority study, approved by PCOM's institutional review board (IRB), compared Bladder AI measurements to human measurements in 58 non-pregnant subjects. The study concluded that Bladder AI volume measurement was non-inferior to human measurements (p<.001), with a mean difference of -0.0228ml (95% CI -0.074, 0.028), demonstrating strong overall agreement and correct identification of imaging planes.

Override Rate Data

While specific override rate data is not publicly detailed, the FDA clearance document for a related Clarius AI product (Clarius Prostate AI, which references Bladder AI as a predicate) indicates that the user retains responsibility for confirming measurement validity and has the option to manually adjust measurements.

Guideline Update Frequency

The FDA clearance process for Clarius AI models, including Bladder AI, involves a 'Predetermined Change Control Plan (PCCP)' for modifications to the AI algorithm, ensuring ongoing safety and effectiveness.

Clinical Workflow Integration

Clarius Bladder AI is integrated into the Clarius App, compatible with iOS and Android devices, and works with Clarius PAL HD3, PA HD3, and C3 HD3 wireless handheld ultrasound scanners. It automates bladder volume measurements in seconds, streamlining workflow and improving efficiency by eliminating tedious manual steps. The system automatically optimizes imaging settings like depth and gain, and provides an adjustable AI overlay to highlight the bladder. It also offers a versatile, cost-effective solution by integrating bladder scanning with whole-body HD ultrasound capabilities.

Physician Tip

Clarius Bladder AI can significantly enhance efficiency in assessing bladder volume, particularly for urinary retention and bladder emptying. Utilize the real-time feedback and automatic measurements to quickly guide decisions on catheterization or further investigation. Remember that while the AI provides accurate measurements, clinical judgment remains paramount, and manual adjustments are possible if needed. The integration with whole-body ultrasound capabilities makes it a versatile tool for various clinical settings.

Clarius Bladder AI is seamlessly integrated within the Clarius Ultrasound App, supporting iOS and Android mobile devices. It is compatible with specific Clarius wireless handheld ultrasound scanners (PAL HD3, PA HD3, C3 HD3). This integration allows for a unified workflow for bladder scanning alongside other ultrasound examinations, potentially reducing the need for dedicated bladder scanners.

At a glance

Pricing 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.

Deployment Mobile App (iOS And Android) Connected To Clarius HD3 Wireless Handheld Ultrasound Scanners.

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Details

Category	Clinical Decision Support & Reference, Radiology & Imaging AI
Pricing	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. Scanner + Annual Membership: $2,995 + $595/year; One-time Scanner Purchase: $4,900+ (membership for AI features required for both)
Deployment	Mobile app (iOS and Android) connected to Clarius HD3 wireless handheld ultrasound scanners.
Compliance
BAA Available	Unknown AI-estimated
HIPAA Compliant	Yes AI-estimated
FDA Status	1 AI-estimated Clarius Bladder AI received 510(k) clearance from the U.S. Food and Drug Administration (FDA) on January 9, 2024, under K232257. It is cleared as an automated radiological image processing software for semi-automatic non-invasive measurements of bladder volume on ultrasound data acquired by Clarius Ultrasound Scanners.
Integrations
EHR	Not specified
Specialties	Emergency Medicine, Radiology, Urology

What the Web Says

Clarius Bladder AI is an FDA-cleared, non-invasive tool that automatically measures bladder volume in seconds, designed for use with Clarius' wireless handheld ultrasound scanners (PAL HD3, PA HD3, and C3 HD3). It aims to improve workflow efficiency, diagnostic accuracy, and patient care by providing real-time feedback for conditions like urinary retention and neurogenic bladder. The technology is also available for veterinary use (Clarius VET Bladder AI) to assist in estimating bladder volume in animals.

Overall: Positive

Strengths

Automated and accurate bladder volume measurement in seconds.
Cost-effective and versatile alternative to dedicated bladder scanners, offering whole-body ultrasound capabilities.
Reduces tedious manual calculation steps and operator variability.
Provides real-time feedback to clinicians, aiding in quick decision-making.
Can reduce inappropriate catheter use and associated healthcare costs.
High image quality comparable to traditional cart-based systems.

Limitations

Requires Clarius Membership for access to advanced features like Bladder AI.
Potential for poor wireless connection and slower frame rates with some Android devices.
Initial connection time can be a pain point.
Accuracy of automatic bladder volume measurements may be reduced in very small or very large animals (VET version).
AI-generated content may be incorrect and requires user verification (VET version).
Some users report issues with customer service and defective products.

Based on reviews from: PR Newswire, FDA Clears AI-Powered Bladder Volume Measurement for Handheld Ultrasound, YouTube (Clarius Mobile Health), Axis Imaging News, Clarius VET Bladder AI, Health Canada Approves Clarius Dual-Array Wireless Scanner and Clarius Bladder AI, AuntMinnie, ICS 2024 Abstract #644 A Deep Learning Model to automate bladder volume using Clarius Handheld Ultrasound, Medical Device Network, Clarius PAL HD3 Review: The AI Handheld Ultrasound That Teaches You While You Scan, Reddit (r/medicine), Reddit (r/pocus), The Medical Futurist, Reddit (r/anesthesiology), Clarius Ultrasound App - Ratings & Reviews, YouTube (Clarius Bladder AI), Reddit (r/hospitalmedicine), Reddit (r/nursing)

Last updated: 2026-07-20

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Press & Coverage

PR Newswire

Clarius Adds AI-Driven Automatic Bladder Volume Measurements to its Wireless Handheld Ultrasound Scanners Designed for Acute Care, Urology, and Nursing

Clarius Mobile Health announced FDA 510(k) clearance for its new Clarius Bladder AI, a non-invasive tool that automatically measures bladder volume in seconds, available with specific Clarius wireless handheld ultrasound scanners.

2024-01

Axis Imaging News

FDA Clears Clarius Mobile Health Bladder AI Scanner

Clarius Mobile Health has received U.S. FDA 510(k) clearance for the Clarius Bladder AI, which provides non-invasive bladder volume measurements and is available for use with several Clarius wireless handheld ultrasound scanners.

2024-01

AuntMinnie

Clarius gets FDA nod for bladder AI tool

Clarius Mobile Health received 510(k) clearance from the U.S. FDA for its new Clarius Bladder AI, a noninvasive tool that automatically measures bladder volume and provides real-time feedback to clinicians.

2024-01

Diagnostic Imaging

FDA Clears AI-Powered Bladder Volume Measurement for Handheld Ultrasound

The Clarius Bladder AI ultrasound software, offering automated bladder volume measurements in seconds, has garnered 510(k) clearance from the FDA and is particularly useful for assessing urinary retention and bladder emptying.

2024-01

Medical Device Network

Clarius' new Bladder AI tool receives FDA 510(k) clearance

Clarius Mobile Health has received US FDA 510(k) clearance for its Clarius Bladder AI non-invasive tool, designed to automatically measure bladder volume, serving as a cost-effective alternative to traditional bladder scanners.

2024-01

Fierce Biotech

Clarius tacks on European nod for whole-body hand-held ultrasound scanner

Clarius also earned FDA 510(k) clearance for Clarius Bladder AI, a new feature that automatically measures bladder volume in real time during a scan and is included in the Clarius membership.

2024-01

F&F Research

Portable Ultrasound Bladder Scanner Market Size to Surge USD 415.19 Mn by 2034

In January 2024, the U.S. FDA provided 510(k) clearance for the Clarius Bladder AI, a non-invasive tool that automatically measures bladder volume in seconds, developed by Clarius Mobile Health.

2024-01

Clarius Mobile Health

Introducing Clarius Bladder AI: Automated Bladder Volume Measurement

This video introduces Clarius Bladder AI, a new feature for Clarius wireless handheld ultrasound scanners, demonstrating how the AI-driven technology provides automatic bladder volume measurements in seconds, enhancing accuracy and efficiency.

2024-01

Videos

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

Clarius Bladder AI

Clarius Mobile Health

Clarius Bladder AI

Clarius Mobile Health

Bladder Volume Measurements Using Clarius AI

Clarius Mobile Health

Clarius Bladder AI with the PAL Scanner

Clarius Mobile Health

Post Void Bladder Volume Measurement with Bladder AI

Clarius Mobile Health

New Clarius Bladder AI is Now Available for Acute Care, Urology and Nursing

Clarius Mobile Health

View all on YouTube

Frequently Asked Questions

How does Clarius Bladder AI assist in clinical practice and what are its primary use cases?

Clarius Bladder AI is a non-invasive tool that automatically and accurately measures bladder volume in seconds, providing real-time feedback to clinicians. It is particularly useful for monitoring urinary retention, assessing bladder emptying in patients with neurogenic bladder or urinary tract obstruction, and evaluating urinary incontinence. This AI-driven solution streamlines workflow by removing tedious manual calculation steps, helping physicians quickly identify patients who may need catheterization or further investigation.

What regulatory compliance has Clarius Bladder AI achieved to ensure its safety and efficacy?

Clarius Bladder AI has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), affirming its safety and effectiveness as a non-invasive tool for automatic bladder volume measurement. This clearance allows its use in the United States with compatible Clarius wireless handheld ultrasound scanners. The user, a healthcare professional trained in ultrasound, retains the responsibility of confirming the validity of measurements based on clinical judgment.

What are the alternatives to Clarius Bladder AI for bladder volume measurement, and how does it compare?

Alternatives include dedicated bladder scanners, such as BladderScan i10, and other handheld ultrasound devices like Butterfly iQ+ or GE Vscan Air CL, which may also offer bladder volume tools. Clarius Bladder AI stands out as a versatile and cost-effective solution, integrating bladder scanning with whole-body HD ultrasound capabilities on a single device, unlike many single-purpose dedicated bladder scanners.

What is the pricing model for Clarius Bladder AI, and are there any ongoing costs?

Clarius Bladder AI is typically included as part of the Advanced Primary/Critical Care Package, which is available with a Clarius Membership. While Clarius scanners start at approximately $3,595, an annual membership fee, around $595/year, is practically essential for accessing advanced features like Bladder AI, cloud storage, and Doppler modes.

What are the known limitations or potential inaccuracies of Clarius Bladder AI that physicians should be aware of?

While Clarius Bladder AI offers high accuracy, studies indicate that bladder volume estimations can be influenced by bladder size and shape, with some underestimation observed, particularly with very large bladder volumes. The AI is an assistive tool and is not intended to replace clinical decision-making, requiring the clinician to retain ultimate responsibility for confirming measurements. Poor imaging quality can also preclude analysis by the AI-based tool.

Can Clarius Bladder AI be integrated into existing electronic health record (EHR) systems?

Clarius ultrasound devices, which host the Bladder AI feature, offer cloud storage for managing examinations and creating reports. While direct EHR integration specifics are not explicitly detailed for Bladder AI, the Clarius platform generally supports a workflow that allows for report generation and potential data export, which can then be incorporated into EHR systems.

What level of training is required for a physician or healthcare professional to effectively use Clarius Bladder AI?

The use of Clarius Bladder AI is intended for healthcare professionals who are trained and qualified in ultrasound. While the AI simplifies bladder volume measurement, proper technique in acquiring ultrasound data and clinical judgment remain crucial for accurate interpretation and patient management.