Butterfly Gestational Age Tool

by Butterfly Network  · Based in United States → — Transforming point-of-care ultrasound. Bringing the power of ultrasound into your assessment, diagnosis and treatment.
Emergency Medicine Family Medicine Obstetrics & Gynecology

Starts at $2,699 for the handheld probe, plus a required membership subscription.
Documentation ProvidedRegulatory Status Disclosed

Overview

The Butterfly Gestational Age Tool is an artificial intelligence-powered feature integrated into the Butterfly iQ+ point-of-care ultrasound system. Designed to assist healthcare professionals, particularly in obstetrics and gynecology, this tool leverages AI to provide automated and rapid estimations of gestational age directly from ultrasound images.

By automating the measurement and calculation process, the tool aims to reduce variability and improve efficiency in clinical workflows. It is particularly beneficial in settings where quick and reliable gestational age assessment is crucial for patient management and care planning.

The integration of this AI tool into the portable Butterfly iQ+ device makes advanced ultrasound capabilities more accessible, enabling clinicians to perform assessments at the point of care, whether in a clinic, hospital, or remote setting. This enhances diagnostic capabilities and supports timely decision-making for pregnant patients.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered gestational age estimation
  • Automated biometric measurements
  • Integrated with Butterfly iQ+ point-of-care ultrasound
  • Real-time analysis
  • Streamlined workflow for OB/GYN assessments

Use Cases

  • First-trimester gestational age assessment
  • Routine prenatal care
  • Emergency department evaluation of pregnant patients
  • Remote and rural healthcare settings
  • Clinical training and education

What Physicians Need to Know

Ultrasound Image Analysis
The Butterfly Gestational Age Tool utilizes AI-powered blind-sweep ultrasound to estimate gestational age. It analyzes ultrasound data to provide timely information for prenatal care, eliminating the need for manual image capture, interpretation, or fetal biometric measurements.
Pregnancy Risk Assessment
Accurate gestational age assessment is crucial for guiding prenatal care, timing key prenatal screenings, and detecting complications sooner, which can ultimately improve outcomes for mothers and babies.
Maternal Health Monitoring
The tool helps address critical gaps in maternal care, particularly in regions with limited access to ultrasound and trained specialists, such as rural U.S. communities and low- and middle-income countries.
Prenatal Testing Integration
By providing a rapid and reliable gestational age estimate, the tool enables clinicians to time key prenatal screenings more effectively.
Physician Tip

The Butterfly Gestational Age Tool is an adjunctive AI-powered ultrasound tool designed for qualified and trained healthcare professionals to estimate gestational age in singleton intrauterine pregnancies between 16-37 weeks. It provides a reliable estimate in under two minutes using a fully automated, three-step blind-sweep process: entering fundal height, applying gel, and performing guided sweeps. This minimizes user variability and eliminates the need for image capture, interpretation, or fetal biometric measurements. It is particularly useful in emergency settings when gestational age is unknown or in resource-limited areas where access to traditional ultrasound and specialists is scarce. However, it is not intended for prenatal management and/or delivery planning, nor for changing an established gestational age from earlier measurements. Caution should be exercised in cases of multiple fetuses, pregnancies outside the 16-37 week range, maternal BMI exceeding 40, known major fetal malformations, or co-morbid conditions affecting fetal size or growth.

The Butterfly Gestational Age Tool is integrated directly into the Butterfly app and is available for use with Butterfly iQ+, and iQ3 handheld ultrasound probes on compatible tablet devices. The AI model was developed in collaboration with the University of North Carolina at Chapel Hill and trained on over 21 million images across diverse patient demographics. This integration allows for rapid and accessible gestational age assessment at the point of care, expanding ultrasound access globally.

Details

Category OB/GYN AI, Radiology & Imaging AI
Pricing Starts at $2,699 for the handheld probe, plus a required membership subscription.
  • Pricing varies based on model (iQ+, iQ3), software membership tier, and whether the purchase is for individual or enterprise use
  • Enterprise pricing includes additional workflow tools, analytics, and volume options
  • The membership unlocks cloud storage, AI-powered features, and ongoing software updates
DeploymentCloud-based, integrated with the Butterfly app on compatible iPhone or Android smartphones or tablets.
Mobile App1
LanguagesEnglish
TrainingUnknown
Target SizeUsed by a wide range of healthcare professionals including emergency physicians, hospitalists, intensivists, cardiologists, anesthesiologists, primary care providers, nurses, paramedics, military medics, and medical students. Deployed in emergency departments, ICUs, operating rooms, outpatient clinics, primary care practices, and remote or resource-limited settings.
Compliance
BAA Available Yes AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Cleared AI-estimated

The Butterfly Gestational Age Tool received FDA clearance in March 2026. It is indicated to provide an output of gestational age (GA) for a singleton intrauterine pregnancy presumed to be between 16-37 weeks gestation. The tool is for use by qualified and trained healthcare professionals in environments where healthcare is provided and is not intended for prenatal management and/or delivery planning. The Butterfly iQ, iQ+, and iQ3 devices are FDA-cleared handheld ultrasound devices. The Butterfly iQ received FDA 510(k) clearance for 13 clinical applications in 2017.

Integrations
EHR Not specified
Specialties Emergency Medicine, Family Medicine, Obstetrics & Gynecology

Social Proof

Customers145,000+ customers worldwide.
Notable
Has sold to or has agreements in place with the majority of the largest 100 hospitals in the United States. Collaborates with the University of North Carolina at Chapel Hill for AI model development. The Bill & Melinda Gates Foundation has provided funding and supported deployment in Malawi and Uganda.

Support & Reliability

Training ProvidedUnknown

What the Web Says

The Butterfly Gestational Age (GA) Tool is an AI-powered, FDA-cleared ultrasound system designed to estimate gestational age in singleton intrauterine pregnancies between 16 and 37 weeks. It aims to address gaps in maternal care, particularly in underserved regions and emergency situations, by providing rapid and accurate gestational age estimates without the need for extensive training or manual interpretation. The tool is integrated into Butterfly's handheld ultrasound devices (iQ+ and iQ3) and utilizes a blind-sweep method.

Overall: Positive

Strengths

  • Provides rapid gestational age estimates (under 2 minutes).
  • Eliminates the need for image capture, manual interpretation, or fetal biometric measurements, reducing variability.
  • Can be used by non-specialist providers and those with no prior sonography training.
  • Offers accuracy comparable to sonographer-performed assessments.
  • Increases access to timely and accurate pregnancy dating, especially in rural and low-resource settings.
  • Aids in guiding prenatal screening, detecting complications sooner, and improving maternal and infant outcomes.

Limitations

  • Not a replacement for the standard of care (GA from Ultrasound based Biometry).
  • Not recommended for multiple fetuses, pregnancies outside of 16-37 weeks, patients with BMI over 40, or fetuses with known malformations/anomalies.
  • Output will not be used to change an established gestational age or estimated due date from earlier measurements.
  • Requires Butterfly iQ+ or iQ3 probes and compatible tablet devices.
  • Some users have reported that the image quality of older Butterfly iQ models is not as good as professional ultrasounds.
  • The company transitioned to a subscription service for its technology, which some existing users found problematic.

Based on reviews from: Reddit, Butterfly Network Support, HLTH, RadAI Slice, UNC Research, Applied Radiology, MedPage Today, YouTube, Imaging Technology News, App Store - Butterfly iQ u2014 Ultrasound, Zebra Medical, PMC, MDEdge

Last updated: 2026-08-21

Ratings & Reviews

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Press & Coverage

Butterfly Network
Butterfly Network Secures First FDA Clearance for Blind Sweep Ultrasound AI Tool, Marking a Major Stride for Women's Health
Butterfly Network received FDA clearance for its fully automated Gestational Age (GA) Tool, the first FDA-cleared blind-sweep ultrasound AI tool for estimating gestational age, designed to improve maternal and fetal outcomes.
2026-03
Butterfly Network
Butterfly Launches AI Gestational Age Tool in Sub-Saharan Africa to Improve Maternal Health
Butterfly Network launched its AI-powered Gestational Age tool in Malawi and Uganda, aiming to improve maternal and fetal health in low-resource settings through AI-aided point-of-care ultrasound.
2025-10
AI CERTs News
Portable Medical AI Reshapes Butterfly Ultrasound - AI CERTs News
This article discusses Butterfly's gestational-age tool, launched in October 2025, which estimates fetal age from blind sweeps and was trained on African population data to enhance accuracy and address critical care gaps in obstetric medicine.
2025-11
RadAI Slice
Butterfly Gestational Age Tool | FDA Radiology AI Device - RadAI Slice
The Butterfly Gestational Age Tool, an ultrasound-based AI system from Butterfly Network, Inc., received FDA 510(k) clearance on March 27, 2026, to assist clinicians in determining fetal gestational age.
2026-03
FDA
K252148 - 510(k) Premarket Notification - FDA
This FDA 510(k) Premarket Notification document details the clearance for the Butterfly Gestational Age Tool (K252148) from Butterfly Network, Inc., with a classification product code of IYN.
2026-04
Voxilens
AI In Healthcare Across Sub-Saharan Africa - Voxilens
The Butterfly Gestational Age tool, launched in October 2025 in Malawi and Uganda, utilizes a 'blind sweep' method for gestational age estimation, trained on African population data to address data bias and improve access to care.
2026-04
FDA
Artificial Intelligence-Enabled Medical Devices - FDA
The FDA's list of Artificial Intelligence-Enabled Medical Devices includes the Butterfly Gestational Age Tool from Butterfly Network, Inc., which received authorization on March 27, 2026.
2026-06
Manuals+
Butterfly Network 950-20054-00 iQ3 Personal Ultrasound System User Manual - Manuals+
The user manual for the Butterfly iQ3 Personal Ultrasound System states that the Butterfly Gestational Age tool is intended to provide a gestational age estimate for a single fetus between 14 and 37 weeks of gestation, available with the iQ3 probe.
unknown

Videos

Product demos, reviews, and walkthroughs for Butterfly Gestational Age Tool.

View all on YouTube

Frequently Asked Questions

The Butterfly Gestational Age Tool is an AI-powered, ultrasound-based system that estimates gestational age using a 'blind-sweep' method, eliminating the need for traditional image capture or fetal biometric measurements. It's designed for rapid decision-making in emergency settings when gestational age is unknown, expanding access to prenatal care in underserved regions, and improving care in rural communities.
The tool is not recommended for multiple fetuses, pregnancies below 16 or over 37 weeks gestation, patients with a BMI exceeding 40, fetuses with known major malformations, or pregnant patients with co-morbid conditions like hypertension or diabetes that may affect fetal size or growth. It is an assistive tool and not a replacement for the standard of care (GA from Ultrasound based Biometry), and its output should not be used to change an established gestational age or estimated due date from earlier measurements.
Yes, the Butterfly Gestational Age Tool has received FDA clearance. It is intended for use by qualified and trained healthcare professionals in healthcare environments. While it provides adjunctive information, it is not intended for prenatal management or delivery planning.
Several other handheld AI-powered ultrasound devices are available for point-of-care gestational age assessment, including GE Vscan Airu2122 SL with Caption AIu2122, Clarius OB AI, and BabyChecker. These tools also aim to make obstetrical ultrasound more accessible and reduce the need for specialist sonographers, particularly in low-resource settings.
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. The iQ3 model is also available, and trade-in options for older devices may be offered.

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Suggest an Edit → | Last Verified: 2026-08-19 | First Added: 2026-08-19
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