AI-enabled Ultrasound Technology (licensed to Butterfly Network)

by Butterfly Network  · Based in United States → — Transforming point-of-care ultrasound.
Maternal-Fetal Medicine Obstetrics & Gynecology Radiology
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Starts at $2,699 for the handheld probe, plus a required membership subscription.

Overview

The AI-enabled Ultrasound Technology, licensed by the University of North Carolina at Chapel Hill to Butterfly Network, is an artificial intelligence tool integrated into Butterfly Network’s handheld ultrasound platform.

  • What it does: This technology primarily enables the estimation of fetal gestational age from standardized “blind sweep” ultrasound videos. It is designed to perform this function without requiring expert image acquisition or interpretation, and it eliminates the need for manual image capture, interpretation, or fetal biometric measurements. The system uses a deep learning-based blind-sweep method to estimate gestational age in under two minutes.
  • Who it is for: This tool is intended for healthcare providers in various specialties and care settings, particularly those where conventional ultrasound services are limited or unavailable. This includes rural and underserved areas, as well as low- and middle-income countries, to expand access to essential obstetric care. It is designed for use by non-specialist providers.
  • How it fits a clinical or practice workflow: The technology streamlines the process of obtaining gestational age by guiding the user through a simple three-step process: entering fundal height, applying gel, and performing guided probe sweeps. This reduces variability and the reliance on highly trained sonographers. The goal is to decouple image acquisition from interpretation, making high-quality obstetric assessment more accessible in diverse care settings.
  • Notable capabilities: A key capability is its ability to provide accurate pregnancy dating in resource-constrained environments. The underlying technology has been in research use across 12 countries for global maternal health programs. The AI model was trained on over 21 million ultrasound images and provides results comparable to sonographer-performed assessments for pregnancies between 16 and 37 weeks.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-enabled fetal gestational age estimation from 'blind sweep' ultrasound videos
  • Handheld, single-probe, whole-body ultrasound system (Butterfly iQ family)
  • Ultrasound-on-Chipu2122 technology for multi-mode imaging
  • AI-powered image guidance tools for real-time feedback
  • CompassAIu2122 enterprise software for automated documentation, quality assurance, and billing
  • Cloud storage and workflow tools
  • 3D imaging advances with iQ Slice and iQ Fan (on iQ3)
  • Over 20 anatomical presets and six imaging modes
  • TeleGuidanceu2122 for remote assistance
  • Educational offerings (Butterfly Academy, ScanLab)

Use Cases

  • Accurate pregnancy dating in resource-constrained environments
  • Expanding access to obstetric ultrasound in rural and underserved areas
  • Rapid decision-making in emergency settings when gestational age is unknown
  • Improved prenatal care in areas with limited access to specialists
  • Point-of-care ultrasound across various clinical settings (hospitals, ambulatory, frontline)
  • Training and education for point-of-care ultrasound

What Physicians Need to Know

Evidence Base
The AI model for gestational age estimation was trained on over 21 million ultrasound images from diverse patient demographics and care settings. This extensive dataset contributes to its ability to deliver consistent results.
Clinical Validation Studies
A study published in the New England Journal of Medicine, led by University of North Carolina researchers, found that the AI algorithm, incorporating Butterfly iQ technology, estimated gestational age with accuracy similar to that of trained sonographers using blindly obtained ultrasound sweeps. The tool provides estimates for pregnancies between 16 and 37 weeks with accuracy comparable to traditional sonographer-performed biometry. In a primary evaluation window of 14 to 27 weeks, untrained providers using the Butterfly device and AI tool produced gestational age estimates equivalent to an expert sonographer using a high-specification machine. For the 28 to 36-week window, the AI gestational age tool demonstrated superiority, beating the expert estimate by approximately 1 day.
Alert Fatigue Management
The Gestational Age (GA) Tool is designed to minimize user variability and deliver rapid insights by eliminating the need for image capture, interpretation, or fetal biometric measurements. This streamlined process, which involves entering fundal height, applying gel, and performing guided sweeps, aims to reduce the cognitive load on clinicians.
Clinical Workflow Integration
The AI-enabled ultrasound technology is integrated directly into the Butterfly app. Butterfly Network's CompassAIu2122 enterprise software is designed to automate documentation, quality assurance, and billing workflows for point-of-care ultrasound programs, enabling documentation compliance rates of up to 94% without adding work for clinicians. Compass AI also offers features like ambient voice dictation for notes, AI-powered image review, and seamless integration with EHRs, PACS, and SSO to route studies directly into the medical record. The system aims to make high-quality obstetric assessment accessible beyond traditional care settings, including rural and underserved areas.
Decision Audit Trail
Butterfly's CompassAIu2122 enterprise software includes a Program Dashboard that tracks usage, compliance, credentialing, and unbilled scans, providing visibility and governance for scaling POCUS programs. This dashboard can help administrators monitor the use of Butterfly and other POCUS devices across their program.
Physician Tip

This AI-enabled ultrasound tool for gestational age estimation can significantly expand access to essential obstetric care, particularly in resource-limited settings and rural areas. Its 'blind sweep' method and automated interpretation reduce the need for expert sonography skills, allowing a wider range of healthcare professionals, including nurse midwives and lower-skilled workers, to accurately estimate gestational age. This can lead to earlier detection of complications, timely prenatal screenings, and improved maternal and fetal outcomes. The integration with Butterfly's workflow management software can also streamline documentation and billing, reducing administrative burden.

The AI-enabled ultrasound technology is integrated into the Butterfly app and is compatible with Butterfly's iQ+ and iQ3 ultrasound systems. Butterfly's CompassAIu2122 enterprise software seamlessly integrates with EHRs, PACS, and Single Sign-On (SSO) systems to facilitate routing studies directly into the medical record and prevent lost images. Butterfly also offers a Software Development Kit (SDK) and APIs for third-party developers to build new AI applications that work with its imaging platform. This open platform approach allows for expanded capabilities, such as the integration of Caption Health's AI-guided software for cardiac ultrasound image capture and interpretation and UltraSight's AI real-time guidance for cardiac imaging.

Details

Category Clinical Decision Support & Reference, OB/GYN AI, Radiology & Imaging AI
Pricing Starts at $2,699 for the handheld probe, plus a required membership subscription.
  • Hardware: Butterfly iQ+ starts at $2,699; Butterfly iQ3 available; Membership: Required subscription for cloud storage, AI features, software updates; Enterprise pricing: Includes workflow tools, analytics, volume options
DeploymentCloud-based solution with handheld hardware.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status Unknown AI-estimated

The AI-enabled ultrasound technology for estimating fetal gestational age received FDA clearance on March 31, 2026. This marks the first FDA-cleared blind-sweep ultrasound AI tool for estimating gestational age.
Integrations
EHR Not specified
Specialties Maternal-Fetal Medicine, Obstetrics & Gynecology, Radiology

What the Web Says

The AI-enabled ultrasound technology, particularly the Butterfly Network's iQ series, has received FDA clearance for its AI-powered gestational age tool, marking a significant advancement in maternal health by enabling accurate pregnancy dating without expert image acquisition or interpretation. This technology aims to expand access to essential obstetric care, especially in rural and underserved areas, and is already in research use across 12 countries. Overall, the technology is praised for its portability, affordability, and AI guidance, making point-of-care ultrasound more accessible to a wider range of healthcare professionals.

Overall: Positive

Strengths

  • Revolutionary portable design at a fraction of traditional ultrasound cost.
  • AI guidance helps non-experts capture diagnostic-quality images.
  • Works with iOS, Android, and Windows devices.
  • Cloud-based storage enables easy sharing and collaboration.
  • Educational tools make it excellent for training.
  • Single probe technology replaces multiple traditional ultrasound probes, making it versatile and cost-effective.

Limitations

  • Probe cost is a significant upfront investment.
  • Image quality may not match high-end cart-based ultrasound.
  • Some advanced features require a subscription.
  • Battery life can be limited during extended use.
  • Can get hot after a while.
  • Software glitches and documentation issues have been reported.

Based on reviews from: Butterfly Network AI Review 2026: AI-Powered Portable Ultrasound, Is the Butterfly Network IQ Ultra Sound Machine really all that it is cracked up to be? - Reddit, UNC Innovation in AI-enabled Ultrasound Receives FDA Clearance, Butterfly Ultrasound and the like - for those of you that have them, do you find them useful or more so a gimmick? : r/anesthesiology - Reddit, Butterfly Network Review 2026: Features, Pricing & Honest Verdict - AI tool, Butterfly Software Pricing, Alternatives & More 2026 - Capterra, What do you guys think of the Butterfly iQ+ portable ultrasound? : r/medicine - Reddit, Butterfly.ai Reviews & Product Details - G2, With ultrasound on a chip, Butterfly Network aims for global reach | Healthcare Dive, We Compared The Butterfly iQ3 With The Philips Lumify : r/BFLY - Reddit, Looking to buy Butterfly iq3 or iq+. What do you think? : r/anesthesiology - Reddit, Butterfly Network Wins FDA Clearance for First Blind-Sweep AI Tool to Estimate Gestational Age | Applied Radiology, Butterfly iQ3: The Clear Answer in Point-of-Care Ultrasound - YouTube, Compass AI | Physician Testimonials: Why Every POCUS Program Needs a Manager, Exploring Butterfly iQ: A Hand-Held Ultrasound Device That Went to Space - TrialX, Butterfly Network Secures First FDA Clearance for Blind Sweep Ultrasound AI Tool, Marking a Major Stride for Women's Health, The clear answer in point-of-care ultrasound | Butterfly iQ3, Butterfly iQ3 Review | Dr. Cecilia Leggett Shares Her Real Clinical Experience - YouTube, ButterflyMX Software Pricing, Alternatives & More 2026 | Capterra, Capterra Reviews 2026: Details, Pricing, & Features - G2, ButterflyMX Products | Read 22 Reviews on G2, ButterflyMX Reviews 2026: Details, Pricing, & Features - G2, Butterfly Network Reviews, Pricing, Features & Integrations | Elion, Butterfly IQ: Review of the portable handheld ultrasound - YouTube

Last updated: 2026-08-05

Ratings & Reviews

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Press & Coverage

Butterfly Network (via BusinessWire)
Butterfly Network Secures First FDA Clearance for Blind Sweep Ultrasound AI Tool, Marking a Major Stride for Women's Health
Butterfly Network announced it received FDA clearance for a fully automated Gestational Age (GA) Tool, the first FDA-cleared blind-sweep ultrasound AI tool for estimating gestational age, which builds on deep-learning models developed by UNC at Chapel Hill.
2026-03
Applied Radiology
Butterfly Network Wins FDA Clearance for First Blind-Sweep AI Tool to Estimate Gestational Age | Applied Radiology
Butterfly Network's new AI-powered Gestational Age (GA) Tool, integrated into its handheld ultrasound platform, received FDA clearance, offering a rapid and simplified method for estimating gestational age without requiring expert image interpretation.
2026-03
UNC Department of Obstetrics and Gynecology
UNC Innovation in AI-enabled Ultrasound Receives FDA Clearance
The University of North Carolina announced that its novel AI-enabled ultrasound technology, invented by Drs. Jeffrey Stringer, Ben Pokaprakarn, and Juan Prieto, has received FDA clearance and has been licensed to Butterfly Network.
2026-03
AuntMinnie
Butterfly secures FDA clearance for gestational age ultrasound AI tool - AuntMinnie
Butterfly Network's AI-powered blind-sweep method for gestational age estimation, integrated into its handheld ultrasound system, has received FDA clearance, allowing for rapid and accurate assessments in under two minutes.
2026-03
RAPS
Recon: Insilico, Eli Lilly strike $2.75B AI drug development deal; FDA clears Butterfly Network's AI ultrasound pregnancy tool | RAPS
This article mentions the FDA clearance of Butterfly Network's AI ultrasound pregnancy tool in the context of other regulatory news in the life sciences sector.
2026-03
Healthcare Dive
With ultrasound on a chip, Butterfly Network aims for global reach | Healthcare Dive
Butterfly Network, known for its handheld imaging machines, received FDA clearance last month for an AI tool to estimate gestational age, aiming to make ultrasound technology more accessible and affordable globally.
2026-04
Trend Hunter
AI-Enhanced Ultrasound Technologies: Butterfly Network Makes Strides in Cardiovascularu2026 | Trend Hunter
Butterfly Network is integrating AI with its portable ultrasound technology, as evidenced by research published in the European Heart Journal showing machine learning models on Butterfly iQ+ devices can identify aortic stenosis with high accuracy.
2025-08
UNC School of Medicine
UNC Research Validates AI-Powered Gestational Age Calculator Used on Butterfly iQ+ for Global Pregnancy Care
A study by UNC School of Medicine researchers demonstrated that an AI tool developed at UNC and deployed on the Butterfly iQ+ handheld ultrasound probe can accurately measure gestational age, even by providers with no prior sonography training.
2023-10

Videos

Product demos, reviews, and walkthroughs for AI-enabled Ultrasound Technology (licensed to Butterfly Network).

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Frequently Asked Questions

Butterfly Network's AI-enabled ultrasound technology enhances clinical decision-making by integrating AI across image capture, clinical workflows, and enterprise management. On-device AI tools assist with image guidance, anatomy identification, and real-time feedback, helping clinicians acquire better images faster and improving the reliability of findings. Additionally, enterprise software like CompassAIu2122 automates documentation, quality assurance, and billing, streamlining workflows and potentially capturing revenue from previously undocumented scans.
Butterfly Network has received FDA clearance for several AI-powered tools. Notably, they received clearance for a fully automated Gestational Age (GA) Tool, which is the first FDA-cleared blind-sweep ultrasound AI tool for estimating gestational age. This tool can determine how far along a pregnancy is in minutes, without requiring expert image acquisition or interpretation, and is designed to minimize user variability. They also have an FDA-cleared AI tool for point-of-care lung ultrasounds that provides an accurate B-line count from a six-second clip, aiding in the rapid assessment of lung issues.
Butterfly Network's technology addresses compliance by securely transmitting ultrasound image data from the mobile app to the Butterfly Cloud using HTTPS with TLS 1.2 encryption, both in transit and at rest. The Butterfly Cloud Hospital Connector creates an encrypted connection between the hospital's DICOM endpoints, Electronic Medical Record (EMR), and other third-party ultrasound devices, facilitating secure data interchange for billing and continuity of care. This integration aims to ensure patient data security and streamline administrative workflows.
Alternatives to Butterfly Network's AI-enabled ultrasound include devices like GE Vscan Air, Clarius HD3, and DRSONO Tri-scan Max. While Butterfly iQ3 offers whole-body imaging with a single probe and AI guidance, GE Vscan Air models are noted for superior image quality, especially in cardiac and vascular workflows. Clarius HD3 provides high-performance, specialty-specific wireless probes with AI, and DRSONO Tri-scan Max offers three probe types in one transducer with a longer battery life and multi-OS compatibility.
The Butterfly iQ+ handheld probe starts at $2,699, with pricing varying based on the model, software membership tier, and whether it's for individual or enterprise use. A Butterfly membership subscription is required, which unlocks cloud storage, AI-powered features, and ongoing software updates, costing around $299 per year for a single user. Enterprise pricing includes additional workflow tools, analytics, and volume options, and there are also training packages available.
Physicians should be aware that while Butterfly Network's AI-enabled ultrasound offers portability and accessibility, its image quality may not be as crisp as high-end cart-based systems for specialized applications like echocardiography or vascular surgery. The single transducer design can limit optimization for specific anatomical targets, and probe ergonomics may not suit all clinical applications. Additionally, a subscription model adds ongoing costs, and extended use can significantly drain the battery of the connected phone.
Butterfly Network's AI tools are designed to assist clinicians, including those without extensive sonography expertise, in both image acquisition and interpretation. On-device AI provides guidance for proper probe positioning, anatomy identification, and real-time feedback, helping users acquire better images faster. For example, the FDA-cleared Gestational Age Tool uses a blind-sweep method to estimate gestational age without requiring image capture, interpretation, or fetal biometric measurements, reducing user variability.

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Suggest an Edit → | Last Verified: 2026-08-05 | First Added: 2026-08-05
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