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Clarius

by Clarius Mobile Health

Last verified

Wireless handheld ultrasound scanners with FDA-cleared onboard AI tools for bladder, prostate, OB and cardiac measurement.

Visit Clarius (opens in new tab)Read our methodology

At a glance

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

Independent score  ·  By our public rubric

53/100Solid choice

Editorial rating 4.0 / 5

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

    FDA cleared (6 K-numbers on record)

  • Clinical Integration
    0/6.6

    No EHR integrations listed

  • Evidence Strength
    20.5/26

    3 peer-reviewed papers

  • 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 (6 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 papers13/18

    3 peer-reviewed papers

  • RCT / meta-analysis / systematic review8/8

    1 RCT/Meta-Analysis/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

Wireless handheld ultrasound scanners with FDA-cleared onboard AI tools for bladder, prostate, OB and cardiac measurement.

No public price verified.

Evidence record

FDA decisions
Show 1 more
Peer-reviewed

3 studies on PubMed: 1 observational, 1 other, 1 RCT, published 2024 to 2026. Read the literature summary

Verification
  • Score computed November 2, 2026, method 1.2.0
  • Review written November 2, 2026
Cite this record

MedAI Verdict, Clarius record, https://medaiverdict.com/tools/clarius, version November 2, 2026

Change history
View every change to this record

Bottom line

Clarius Mobile Health sells wireless handheld ultrasound scanners that show the image on a phone or tablet. FDA lists twelve 510(k)s under the company, and six carry AI tool names: Clarius AI, Bladder AI, OB AI, Prostate AI, Median Nerve AI and Ejection Fraction AI. It fits a clinician who scans at the point of care and wants measurements handled by the scanner. Scanner and membership prices are unverified, because the store page did not load.

Which of the vendor's AI features have FDA device names?

The six cleared tools run from K222406 (Clarius AI, January 23, 2023) to K253593 (Ejection Fraction AI, March 2, 2026), after the first Clarius record, K163138, dated November 30, 2016. The vendor's AI page lists more: Auto Preset AI for FAST exams, T-Mode visual guidance in MSK, Primary Care, Aesthetics and Acute Care variants, MSK AI for tendons, Auto Heart Rate, Auto Gain and Vessel Depth AI. None of those has an FDA device name of its own, and whether they sit inside Clarius AI (K222406) or a scanner clearance is unverified. Several tools are marked "Available in select markets", and the page marks features as CE Marked across Europe and the UK.

The home page sorts features by skill level, from Novice (point-and-shoot presets) through Beginner (T-Mode) and Intermediate (AI for workflow and needle guidance) to Expert.

What does PubMed hold on Clarius?

A search on "Clarius" and ultrasound returns 74 results, and none of the first ten concerns the AI tools. The papers examine the scanners. One measured the accuracy of the handheld in prostate morphology and volume (PMID 33677990), one compared handheld probes for transabdominal prostate and bladder volumes, and one compared the Butterfly iQ and the Clarius C3 for obstetric biometry (PMID 38011589).

Who is Clarius?

The About page names Laurent Pelissier, listed as Ultrasonix founder, as founder and CEO, and the first wireless handheld scanner was sold in December 2016. The company claims over 7 million ultrasound scans, 40,000+ clinicians, 70+ countries and 12+ years in business. The vendor cites a TIME World's Top HealthTech Companies 2026 listing. Headquarters, ownership and funding are not stated on the About page.

What is stated about integration, security and sales?

Clarius sells through online stores and takes quote requests through a separate page. Integration with cloud, PACS and EHR systems goes unmentioned, as do HIPAA, SOC 2 and ISO certifications.

The verdict

Clarius fits a point-of-care clinician who wants a wireless scanner with built-in measurement tools, and six AI tools have FDA device names while the other features on the AI page have none of their own. Whether a given AI tool reaches a buyer depends on the market, since several are marked "Available in select markets".

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), CE per vendor documentation. Independent attestation review is the buyer's responsibility before clinical deployment.

What the literature says

3 peer-reviewed studies indexed on PubMed evaluate Clarius in clinical contexts. The most relevant are shown below, ranked by editorial relevance score combining title match, study design, recency, and journal tier.

Can handheld ultrasound probes reliably measure transabdominal prostate and bladder volumes? A prospective randomized point-of-care ultrasound study. (opens in new tab)
Wright HC, Corrigan D, De S· Front Urol· 2024RCT
National guidelines recommend obtaining prostate gland volume (PGV) prior to benign prostate hyperplasia (BPH) surgery. Measurement of PGV with handheld ultrasound (HUS) probes shows promise. To compare the reliability of two HUS probes (Butterfly iQ and Clarius C3) to the BPH guideline-recommended imaging (GIm) for both prostate and bladder volumetrics. Male patients with GIm were randomized to undergo transabdominal HUS PGV with one of the two probes. A subset underwent voided volume measurements with one of the two HUS and a conventional bladder scanner (BS). The reliability of the volume…
Artificial Intelligence-Assisted Lung Ultrasound for Pneumothorax: Diagnostic Accuracy Compared with CT in Emergency and Critical Care. (opens in new tab)
Dal İ, Akyol K· Tomography· 2025Observational
Pneumothorax (PTX) requires rapid recognition in emergency and critical care. Lung ultrasound (LUS) offers a fast, radiation-free alternative to computed tomography (CT), but its accuracy is limited by operator dependence. Artificial intelligence (AI) may standardize interpretation and improve performance.This retrospective single-center study included 46 patients (23 with CT-confirmed PTX and 23 controls). Sixty B-mode and M-mode frames per patient were extracted using a Clarius C3 HD3 wireless device, yielding 2760 images. CT served as the diagnostic reference. Experimental studies were con…
Validation of Handheld Ultrasound Devices for Point of Care Use in Rheumatology Study- Focus on Synovitis, Doppler Activity, Erosions, and Tendon Lesions. (opens in new tab)
Acikgoz SB, Gazel U, Shah S, et al.· J Rheumatol· 2026
Ultrasonography (US) is essential in rheumatology, but conventional systems are costly and not easily portable. Handheld US offers affordable, portable options, yet their diagnostic validity in Psoriatic Arthritis (PsA) is unclear. This study assessed the concurrent validity of handheld US devices in PsA by evaluating agreement with a gold-standard scanner in detecting elementary lesions. PsA patients meeting Classification Criteria for PsA and presenting ≥ tender and swollen joint underwent same-day US with handheld (Clarius-HD3 L20/L15) and gold-standard (GE Logiq E9/E10) systems usi…

See all on PubMed (opens in new tab)

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