Auto 3D Bladder Volume Tool

by Butterfly Network  · Based in United States → — Transforming point-of-care ultrasound.
Emergency Medicine Radiology Urology
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Subscription-based
Regulatory Status Disclosed

Overview

The Butterfly Auto 3D Bladder Volume Tool is a software application package designed for use with Butterfly Network ultrasound systems, such as the Butterfly iQ+ and iQ3. It enables non-invasive, automated measurement of bladder volume to support physician diagnosis in adult populations. The tool acquires a 3D sweep of the bladder region in seconds, automatically calculating and displaying the volume on screen. This AI-powered tool provides accurate and reliable bladder volume measurements, helping clinicians assess urinary retention, monitor bladder function, and avoid unnecessary catheterizations. It features a user-friendly interface with walkthrough guidance for proper probe placement and offers 3D rendering to confirm bladder anatomy and measurement accuracy. The system is integrated with the Butterfly mobile app and Butterfly Cloud, allowing for secure storage and sharing of ultrasound studies.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Automated 3D bladder volume calculation
  • Non-invasive measurement
  • Real-time ultrasound imaging
  • 3D visualization and rendering
  • Guidance for proper probe placement
  • Integration with Butterfly iQ/iQ+ mobile app
  • EHR integration via barcodes
  • Secure cloud storage and sharing (Butterfly Cloud)
  • Durable, water and dust resistant probe
  • AI-powered algorithms for segmentation and volume measurement

Use Cases

  • Assessment of urinary retention
  • Post-operative care
  • Urologic evaluations
  • Monitoring bladder function
  • Bladder training
  • Avoiding unnecessary urinary catheterizations

What Physicians Need to Know

DICOM Support & Standards
Supports DICOM-TLS (Transport Layer Security, v 1.2) for secure, encrypted connections to DICOM endpoints. Allows forwarding ultrasound studies to Picture Archiving and Communication Systems (PACS) and Vendor Neutral Archives (VNA). Can connect to DICOM Modality Worklist (MWL) to reduce manual patient data entry.
PACS Integration Method
Integrates directly into Electronic Health Records (EHR) or PACS via Butterfly Cloud, with auto-forwarding rules for finalized studies. Enterprise customers can utilize Butterfly Link for PACS/VNA integrations. Supports EHR integration by scanning barcodes (Code 128, Aztec Code, Data Matrix, QR Codes) encoding acquired volume.
Reading Room Workflow Impact
Provides automated bladder volume calculations with 3D visualizations in seconds, designed for rapid and accurate measurements. Features a user-friendly interface with on-screen guidance for optimal probe placement. The volume estimate is quickly displayed after a 3D sweep, and acquisitions can be saved to the study roll. The system is designed to replace more expensive bladder scanners and offers immediate access to scans without login or configurations (for iQ+ Bladder system).
AI Model Architecture (deep learning approach)
Utilizes proprietary artificial intelligence for automatic segmentation and volume measurement. The AI model is based on the U-Net image segmentation method and employs a deep neural network (DNN) algorithm to trace bladder fluid contours. Volume calculation is achieved through integration over binary images, combining segmentation results to construct a 3D bladder model.
Processing Speed (per study)
Delivers accurate and reliable bladder volume measurements in less than 6 seconds. The newer generation Butterfly iQ3 offers double the data processing speed and faster 3D capabilities.
FDA Clearance Pathway (510k/De Novo)
Received FDA 510(k) Premarket Notification (K200980) clearance on June 11, 2020, as a Class II device. It demonstrated substantial equivalence to the predicate device, the BladderScan Prime PLUS System.
Supported Modalities
Exclusively supports Ultrasound (US) imaging, specifically with Butterfly iQ, iQ+, and iQ3 ultrasound systems, leveraging Ultrasound-on-Chipu2122 technology.
Sensitivity & Specificity Data
Volume measurement accuracy is u00b17.5mL for volumes 0-100mL and u00b17.5% for 101-740mL. Studies indicate the 3D method has higher accuracy than 2D methods, with a median percentage error of -11.2% to -12.0% and mean bias of -64.9 mL to -72.3 mL. It shows excellent intra-operator reproducibility (ICC > 0.96) and high inter-operator agreement (ICC = 0.977). Volume estimates are highly correlated with true volumes (Pearson correlations > 0.95).
Physician Tip

The Auto 3D Bladder Volume Tool provides rapid, automated bladder volume measurements with 3D visualization, enhancing efficiency in various clinical settings. Its on-screen guidance aids in proper probe placement, simplifying the workflow for both experienced and novice users. While the 3D render is for review and not diagnostic use, the quantitative data offers valuable input for patient management. Consider its utility for quick assessments in urology, post-operative care, and to avoid unnecessary catheterizations. The system's integration capabilities with EHR/PACS streamline documentation.

The Butterfly Auto 3D Bladder Volume Tool integrates with existing healthcare IT infrastructure through Butterfly Cloud, supporting secure DICOM-TLS connections to PACS/VNA and DICOM Modality Worklist for patient data population. For Enterprise customers, Butterfly Link facilitates these integrations. Additionally, acquired volume data can be integrated into EHR systems by scanning various barcode formats, offering flexibility in data transfer and record-keeping.

Details

Category Radiology & Imaging AI
Pricing Subscription-based
  • iQ+ subscription: $420/yr (includes Auto Bladder Volume); iQ3 subscription: $299/yr (includes Auto Bladder Volume); iQ+ Bladder System bundle: $2,299.00 - $3,299.00 (includes probe, software, cart, tablet)
DeploymentIntegrated with Butterfly iQ/iQ+ handheld ultrasound devices; mobile app (iOS); cloud-based (Butterfly Cloud)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The Auto 3D Bladder Volume Tool received FDA 510(k) clearance (K200980) on June 11, 2020, as a Class II medical device. It is designed to view, quantify, and report results acquired on Butterfly Network ultrasound systems for noninvasive volume measurements of the bladder to support physician diagnosis in adult populations.
Integrations
EHR Not specified
Specialties Emergency Medicine, Radiology, Urology

What the Web Says

The Auto 3D Bladder Volume Tool from Butterfly Network generally receives positive feedback for its ease of use and integration with the iQ+ device, making bladder volume measurements more accessible and efficient for healthcare professionals. Reviewers highlight its potential to streamline workflows and reduce the need for specialized equipment, though some minor limitations or desires for further enhancements are occasionally mentioned.

Overall: Positive

Strengths

  • Automated 3D bladder volume calculations improve accuracy and reduce manual errors.
  • Integrated directly into the Butterfly iQ+ device, offering a portable and all-in-one solution.
  • Simplifies the workflow for bladder volume assessments, making it quicker and easier for clinicians.
  • Reduces the need for dedicated, bulky bladder scanners, saving space and cost.
  • User-friendly interface, making it accessible even for those less experienced with ultrasound.
  • Enhances patient comfort by providing a non-invasive and efficient measurement method.

Limitations

  • Requires the Butterfly iQ+ device, limiting use to existing Butterfly users.
  • Accuracy might be influenced by patient anatomy or probe placement in some complex cases.
  • Some users might desire more advanced customization options for reporting or data export.
  • Reliance on a mobile device for display and control might not suit all clinical environments.
  • Potential learning curve for new users unfamiliar with ultrasound or the Butterfly platform.
  • Specific feedback on long-term reliability and software updates is less widely available.

Based on reviews from: Butterfly Network official documentation, Healthcare IT News, Physician forums and reviews, Reddit discussions (r/medicine, r/ultrasound), Medical technology review sites, Clinical case studies and user testimonials

Last updated: 2026-07-17

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Press & Coverage

Butterfly Network | Radiology AI Companies - X-ray Interpreter
Auto 3D Bladder Volume Tool
The Auto 3D Bladder Volume Tool by Butterfly Network is a software application integrated with Butterfly Network ultrasound systems for noninvasive bladder volume measurements. It received FDA approval on June 11, 2020.
2020-06
AuntMinnie
New software portends second revolution in ultrasound
This article from March 2021 discusses how new software applications, including Butterfly Network's Auto 3D Bladder Volume Tool, are driving a second revolution in ultrasound through artificial intelligence. The tool is listed among other AI developments for various ultrasound applications.
2021-03
BMUS
Omdia AI in Medical Imaging Survey | News | BMUS
A May 2022 news item mentions the Auto 3D Bladder Volume Tool by Butterfly Network, highlighting its use of machine learning to quantify bladder volumes and its FDA approval in 2020. It emphasizes that AI ultrasound systems currently support diagnostics rather than acting as standalone systems.
2022-05
accessdata.fda.gov
510(k) Premarket Notification for Auto 3D Bladder Volume Tool
This regulatory document from June 2020 details the FDA's 510(k) clearance for Butterfly Network's Auto 3D Bladder Volume Tool, outlining its intended use for noninvasive bladder volume measurements in adult populations using proprietary AI algorithms.
2020-06
Butterfly Network
iQ+ Bladder specs - Butterfly Network
This page provides technical specifications for the Butterfly IQ+ Bladder Ultrasound System, indicating the Auto 3D Bladder Volume Tool as a software application for noninvasive bladder volume measurements in urology, with FDA regulatory clearance.
unknown
PMC - NIH
Towards Clinical Application of Artificial Intelligence in Ultrasound Imaging
A peer-reviewed article from July 2021 discusses the progress of AI in ultrasound imaging, listing the Auto 3D Bladder Volume Tool by Butterfly Network as one of the FDA-approved AI-powered medical devices for bladder volume measurements.
2021-07
IRIS
Computational healthcare: Present and future perspectives (Review)
This review article from December 2021 includes the Auto 3D Bladder Volume Tool by Butterfly Network as an FDA-approved AI-based application for diagnosis in urology from 2020, within a broader discussion of AI in healthcare.
2021-12
FDA Radiology AI Device
Butterfly Gestational Age Tool | FDA Radiology AI Device
This entry lists Butterfly Network's Auto 3D Bladder Volume Tool with its 2020 510(k) clearance, indicating its status as an FDA-approved radiology AI device.
2020

Videos

Product demos, reviews, and walkthroughs for Auto 3D Bladder Volume Tool.

View all on YouTube

Frequently Asked Questions

This AI tool provides non-invasive bladder volume measurements using transabdominal ultrasound, automating the calculation process within seconds. It enhances workflow efficiency by offering quick, reliable data for assessing urinary retention, post-void residuals, and guiding catheterization decisions in various clinical settings, potentially reducing unnecessary invasive procedures.
Specific Auto 3D Bladder Volume Tools, such as Bladder AI by Exo Imaging and the Butterfly Auto 3D Bladder Volume Tool, are FDA-cleared as Class II medical devices. For data privacy, AI systems handling Protected Health Information (PHI) must comply with regulations like HIPAA and GDPR through measures such as data de-identification, encryption, access controls, and Business Associate Agreements with vendors.
Limitations include dependency on proper image quality and user competence, a risk of over-reliance on the automated system, and potential to overlook atypical cases not well-represented in training data. Some studies also indicate that these tools may underestimate bladder volume compared to the gold standard of catheterization, and technical errors can occasionally occur with very large bladder volumes.
The AI-powered tool offers rapid, automated measurements, often within seconds, improving efficiency over manual methods. While traditional bladder scanners and cart-based ultrasounds can be accurate, 3D AI tools aim to reduce operator variability and enhance ease of use, though some studies suggest they might still underestimate true volume compared to catheterization.
Pricing models for AI healthcare tools can vary, including fixed costs, consumption-based, or linear usage-based models, with regulatory compliance costs influencing the overall price. For handheld ultrasound devices with AI features, a one-time device purchase may be combined with subscription fees for advanced features, cloud storage, or ongoing software updates.
Clinical testing has demonstrated high accuracy and reliability for various Auto 3D Bladder Volume Tools, with strong correlations to manual measurements and consistent performance across diverse patient populations. Studies often compare these tools against the gold standard of catheterization, showing good agreement and reproducibility.
Effective utilization typically requires training, which may include in-app guidance, tutorials, and educational resources provided by the manufacturer. Companies also offer ongoing technical support and training programs to ensure users understand the device's operation, its AI capabilities, and compliance with medical device regulations.

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Suggest an Edit → | Last Verified: 2026-04-17 | First Added: 2026-04-17
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