MedAI Verdict
Radiology

AI Radiology

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Exo

by Exo Imaging, Inc.  ·  US

Last verified

Handheld ultrasound with FDA-cleared AI for cardiac, lung and fluid assessment, for point-of-care clinicians.

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At a glance

Pricing
No public price verified.
HIPAA
Not disclosed
SOC 2
Not disclosed
EHRs
—
Founded
—
HQ
US
On this page

Independent score  ·  By our public rubric

28/100Niche fit

Not rated: too little independent evidence yet.

How it’s computed →
  • Regulatory & Compliance
    18/28

    FDA cleared (8 K-numbers on record)

  • Clinical Integration
    0/6.6

    No EHR integrations listed

  • Evidence Strength
    0/26

    No peer-reviewed coverage

  • Vendor & Market
    3/18

    Seed-stage or unfunded

  • Sentiment & Transparency
    2.5/5

    Pricing on request, no public amounts

▸ Show all 11 dimensions

Regulatory & Compliance

  • FDA clearance18/18

    FDA cleared (8 K-numbers on record)

  • HIPAA / SOC2 / BAA0/10

    No public HIPAA/SOC2/BAA attestation

Clinical Integration

  • 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

Evidence Strength

  • Peer-reviewed papers0/18

    No peer-reviewed coverage

  • RCT / meta-analysis / systematic review0/8

    No RCT, meta-analysis, or systematic review

Vendor & Market

  • Funding & adoption signal3/12

    Seed-stage or unfunded

  • Years in market0/6

    Founded year not recorded

Sentiment & Transparency

  • Pricing transparency3/5

    Pricing on request, no public amounts

Scored November 2, 2026 · Public scoring method v1.2.0

Handheld ultrasound with FDA-cleared AI for cardiac, lung and fluid assessment, for point-of-care clinicians.

No public price verified.

Evidence record

FDA decisions
Show 3 more
Verification
  • Score computed November 2, 2026, method 1.2.0
  • Review written November 2, 2026
Cite this record

MedAI Verdict, Exo record, https://medaiverdict.com/tools/exo, version November 2, 2026

Change history
View every change to this record

Bottom line

Exo Iris is a pocket ultrasound probe with AI built in, sold by Exo Imaging, Inc. of Santa Clara, California. The person holding it is the clinician at the bedside, in emergency care or EMS. FDA's records list eight 510(k) clearances for Exo between August 2021 and February 2026, covering the Iris device and a series of AI modules. A radiology department after worklist triage on CT or X-ray looks to a different product class, since Exo works at the point of care.

What does Exo say Iris does?

Exo says Iris is pocket sized AI ultrasound that replaces carts and probes, with phased, curved and linear probe options on a mobile device or a cart. Its AI comes in four parts. The Cardiac AI Suite offers automated ejection fraction, chamber size, strain and wall thickness. The Lung AI Suite detects B-lines, effusions and consolidations in real time. Fluid Management AI covers IVC collapsibility, bladder volume and vascular access. SweepAI provides scan guidance, anatomy labels, auto-capture and auto-measure, and Exo says it works offline.

Exo Works is the workflow software, which Exo says handles notes, billing and QA and credentialing. Exo names no EHR vendor. Population health tools for thyroid cancer risk and hip dysplasia screening appear on the site with no stated clearance.

What backs the AI?

In June 2025 Exo announced what it called the first FDA-cleared point of care AI for pleural effusion and consolidation, with sensitivity and specificity described only as "excellent". The release cites no K number, and its match to any of the eight clearances is not confirmed.

Four PubMed papers concern Exo's AI. Three look vendor-linked: a 2024 Diagnostics paper on estimating left ventricular ejection fraction from apical echo views in 441 patients (PMID 39202209), and two lung ultrasound studies from 2024 and 2025. Exo hosts a case study page for the ejection fraction paper, and the accuracy figures of 83%, 80% and 91% for an ejection fraction below 50% in the A2C, A4C and PLAX views are the vendor's. Author affiliations are unverified. The fourth paper is a 2025 commentary on barriers to AI in point of care ultrasound.

How is Iris priced?

An August 2026 Exo release describes a subscription free option in which Iris scans immediately after a one time activation. Exo points to its store and a sales operations address for the amount, and the store price is not verified.

The verdict

Iris is built for bedside teams, such as an emergency physician or an EMS crew, that want cardiac, lung and fluid measurements from a pocket probe. Outside evidence is thin: the one accuracy figure set sits on a case study page that Exo hosts.

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.

TierMonthlyAnnualNotes
EnterpriseNot statedNot statedNo public price verified.

Source: vendor pricing page. Last checked November 2, 2026.

What deploys cleanly

Carries FDA 510(k) per vendor documentation. Independent attestation review is the buyer's responsibility before clinical deployment.

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