- Device price, 3-year warranty. Shown with a dollar sign on the page, currency not otherwise stated.
- Not disclosed
- Type II
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Radiology
Butterfly Network
by Butterfly Network, Inc.
Butterfly iQ handheld whole-body ultrasound probe line, with FDA-cleared AI tools for bladder volume and gestational age.
On this page
66/100
Editorial rating 4.5 / 5
- Regulatory & Compliance24/28
FDA cleared (2 K-numbers on record)
- Clinical Integration0/6.6
No EHR integrations listed
- Evidence Strength20.5/26
4 peer-reviewed papers
- Vendor & Market8.4/18
Mid-tier funding and adoption
- Sentiment & Transparency2.5/5
Pricing on request, no public amounts
▸ Show all 11 dimensions▾ Hide dimension detail
- FDA clearance18/18
FDA cleared (2 K-numbers on record)
- HIPAA / SOC2 / BAA6/10
Partial attestation (one of HIPAA / SOC2 / BAA)
- EHR integrations (count)0/4
No EHR integrations listed
- Top-3 EHR coverage (Epic / Oracle / Athena)0/2
None of the top-3 EHRs covered
- Peer-reviewed papers13/18
4 peer-reviewed papers
- RCT / meta-analysis / systematic review8/8
1 RCT/Meta-Analysis/Systematic Review
- Funding & adoption signal8/12
Mid-tier funding and adoption
- Years in market0/6
Founded year not recorded
- Pricing transparency3/5
Pricing on request, no public amounts
Butterfly iQ handheld whole-body ultrasound probe line, with FDA-cleared AI tools for bladder volume and gestational age.
Device price, 3-year warranty. Shown with a dollar sign on the page, currency not otherwise stated. SOC 2 Type II attested.
Evidence record
510(k)K252148 (opens in new tab)March 27, 2026
Butterfly Gestational Age Tool
510(k)K200980 (opens in new tab)June 11, 2020
Auto 3D Bladder Volume Tool
4 studies on PubMed: 3 other, 1 RCT, published 2024 to 2026. Read the literature summary
- Score computed November 2, 2026, method 1.2.0
- Review written November 2, 2026
MedAI Verdict, Butterfly Network record, https://medaiverdict.com/tools/butterfly-network, version November 2, 2026
Bottom line
Butterfly Network sells a handheld ultrasound probe that works with a phone, and AI is a small share of its FDA record. As of November 2026 the pricing page shows public prices for the iQ+ probe at $2,699, the iQ3 at $3,899 and the individual software memberships. The three organization tiers are listed as "Inquire today". An individual clinician buying a probe and a membership works from a posted price list, and a hospital that wants Active Directory, fleet management and archive integration across many probes is on a quote-only tier.
What does Butterfly sell?
The iQ+ and iQ3 are single-probe, whole-body ultrasound devices that the vendor says use patented Ultrasound-on-Chip technology. They connect to a compatible iPhone or Android phone, and TeleGuidance runs on iOS only. The About page names Jonathan M. Rothberg as founder and claims 3000+ probes distributed for global health, 70+ countries and 400+ partners.
The iQ3 page lists an Auto B-lines counter that counts B-lines from a six-second clip, Auto Bladder with 3D visualization, Cardiac Output, Umbilical Artery Doppler, Biplane, NeedleViz, iQ Slice and iQ Fan, and not all of them are labeled AI. Compass AI is the vendor's software for running an ultrasound program, and its footer says it is not intended to provide information used for diagnosis or therapy decisions. On security, Butterfly says it holds a SOC 2 Type 2 attestation from an independent auditor, scoped to the iQ+ ecosystem, and it lists HIPAA among the frameworks it uses without calling it a certification.
How much of the FDA record is AI?
Six 510(k)s run from K163510 (Poseidon Ultrasound System, September 6, 2017) to K252148 (Butterfly Gestational Age Tool, March 27, 2026). Only two carry an AI tool in the device name, the Gestational Age Tool and K200980, the Auto 3D Bladder Volume Tool, dated June 11, 2020. The iQ3 system is K232808, dated January 4, 2024. The Auto B-lines counter, Biplane and Cardiac Output tools have no device name of their own in FDA data. The Gestational Age Tool needs an iQ+ or iQ3 and an Advanced membership.
What do the devices and memberships cost?
The iQ3 is $3,899 with a three-year warranty and the iQ+ is $2,699 with a one-year warranty. A Core Technology membership is $299 a year plus the probe, with one seat and two probes online. Advanced Technology is $420 a year plus the probe and adds Doppler modes, iQ Slice, iQ Fan, Biplane, Needle Viz and the AI tools Auto Bladder Volume and Auto B-Line Counter. A one-time Advanced option is $1,500 plus the probe, with software access guaranteed for five years and no recurring fee.
A trade-in gives up to $1,500 credit toward an iQ3 with no end date shown. The page's Affirm example is $3,119 over 36 months, about $87 a month at 0% APR, depending on credit.
Do papers test the AI tools?
The first ten PubMed results for "Butterfly iQ" are hardware and handling studies. One compared nine handheld devices with 12 examiners (PMID 39272698), one tested obstetric biometry on the Butterfly iQ and the Clarius C3, and one set a handheld device against a bladder scanner and a cart-based machine for bladder volume, which measured the device and not the Auto Bladder tool. The first page has no dedicated accuracy paper for the Auto B-lines counter or gestational age.
The verdict
Butterfly fits an individual clinician who wants a pocket probe at a posted price, with the AI as a small add-on. An organization needing fleet management or archive integration has to request a quote. Auto Bladder Volume and Auto B-Line Counter sit in the $420 yearly Advanced tier.
Editorial review last generated November 2, 2026. Synthesized from clinician sentiment, peer-reviewed coverage, and our editorial silo picks. Refined by hand where vendor facts change.
What it costs
All tiers are custom-quoted. The vendor does not publish per-provider list pricing.
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Butterfly iQ3 device | Not stated | Not stated | Device price, 3-year warranty. Shown with a dollar sign on the page, currency not otherwise stated. |
| Butterfly iQ+ device | Not stated | Not stated | Device price, 1-year warranty. Also stated as starts at $2,699 in the FAQ. |
| Core Technology membership | Not stated | Not stated | Plus probe. 1 seat, 2 probes online. |
| Advanced Technology membership | Not stated | Not stated | Plus probe. Adds Doppler modes, iQ Slice, iQ Fan, Biplane, Needle Viz and the AI tools Auto Bladder Volume and Auto B-Line Counter. |
| Advanced Technology one-time | Not stated | Not stated | Plus probe. Software access guaranteed for 5 years, no recurring fees required. |
Source: vendor pricing page. Last checked November 2, 2026.
What deploys cleanly
Carries FDA 510(k), SOC 2 Type II per vendor documentation. Independent attestation review is the buyer's responsibility before clinical deployment.
What the literature says
4 peer-reviewed studies indexed on PubMed evaluate Butterfly Network in clinical contexts. The most relevant are shown below, ranked by editorial relevance score combining title match, study design, recency, and journal tier.
- Comparison of in-person versus virtual ultrasound instruction for pediatric residents. (opens in new tab)
- Gillon JT, Liu EL, Dutreuil V, et al.· BMC Med Educ· 2024
- Point-of-care ultrasound (POCUS) instruction is prevalent in medical schools but not in pediatric residency programs, even though the majority of pediatric residents desire POCUS instruction. Virtual ultrasound instruction with affordable handheld ultrasound devices may help remedy this deficiency by allowing qualified instructors to circumvent geographic and financial limitations to reach this population. This study sought to determine if virtual ultrasound instruction is an effective alternative to traditional in-person instruction in a cohort of pediatric residents for the extended Focused…
- Comparison of Six Handheld Ultrasound Devices by Pediatric Point of Care Ultrasound (POCUS) Experts. (opens in new tab)
- Leung SK, Dancel R, Soni RN, et al.· POCUS J· 2025
- Point of care ultrasound (POCUS) use is increasing among pediatric clinicians, but lack of access to ultrasound devices is a major barrier. The availability of pocket-sized handheld ultrasound devices ("handhelds") has improved access. However, no head-to-head comparative studies of handhelds in children have been performed to guide purchasing decisions. This cross-sectional study compared six handhelds: Butterfly iQ+™ (Butterfly Network Inc.), Clarius® (Clarius Mobile Health™), Kosmos™(EchoNous), TE Air™ (Mindray®), Vscan Air™ SL (General Electric…
- Breast assessment using next generation handheld ultrasound device based on silicon chips: a pilot study in senology. (opens in new tab)
- Plöger R, Ludwig C, Nowozin G, et al.· Arch Gynecol Obstet· 2026
- In breast care, ultrasound examination is a very important tool used to detect breast tumors, to monitor core needle biopsies, for preparing surgical operations, and for tracking postoperative developments. So far, stationary high-end ultrasound devices (SHUD) based on piezoelectric technology are most commonly used but lack the mobility and thus the possibility to practice point-of-care ultrasound (POCUS) in senology. In contrast, handheld ultrasound devices based on silicon chips (HHUD) offer a high mobility and different penetration depths through its all-in-one probe principle and thus ma…
- Feasibility of point-of-care ultrasound training and remote quality assurance for community physicians in conflict-affected Syria. (opens in new tab)
- Dana E, Dichtwald S, Lusky G, et al.· J Ultrasound· 2026
- Point-of-care ultrasound (PoCUS) can extend diagnostic capabilities where conventional imaging is unavailable, yet evidence on its implementation in active conflict zones remains scarce. We describe the operational feasibility of a PoCUS training, device deployment, and remote quality assurance program for community physicians working in village clinics in Syria. Nine physicians from five community clinics, none of whom had prior PoCUS training and whose ultrasound experience was limited to specialty-specific applications, participated in a two-day in-person PoCUS training course adapted to a…
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