Brainomix vs Clarius
Clarius sells hardware. Its wireless handheld ultrasound scanners show the image on a phone or tablet, with AI tools such as Bladder AI, OB AI, Prostate AI, Median Nerve AI and Ejection Fraction AI, the last one decided by the FDA in March 2026. The vendor marks several tools as available in select markets. A urology office measuring bladder and prostate volume, or a clinic screening for carpal tunnel with the median nerve tool, is the buyer. Scanners are bought through Clarius's online stores or a quote form.
Brainomix is software for hospitals that run stroke pathways, analyzing brain scans from CT, CTA, CTP and MRI. The vendor claims 35 or more clearances worldwide against 13 US 510(k) records on openFDA, and it quotes by demo request.
The Clarius pages describe a handheld scanner and the Brainomix pages describe image-reading software, which puts the two purchases in different departments.
Radiology · Reviewed November 2, 2026
Brainomix
by Brainomix Limited · founded 2012
FDA-cleared AI scoring and large vessel occlusion flagging for stroke CT, CTA, CTP and MRI, plus CT lung quantification.
Clarius
by Clarius Mobile Health
Wireless handheld ultrasound scanners with FDA-cleared onboard AI tools for bladder, prostate, OB and cardiac measurement.
When to pick each one
Brainomix
- 13 FDA 510(k) records under Brainomix Limited
- Brain scan analysis for stroke work-ups
- Founded 2012 as an Oxford spinout
Clarius
- Wireless handheld scanner with a phone as display
- Bladder, prostate, OB and median nerve AI
- Ejection Fraction AI decision in March 2026
Score
Each row shows points earned of points available under the published rubric.
Brainomix
64of 100
Clarius
53of 100
| Dimension | Brainomix | Clarius | Difference |
|---|---|---|---|
| FDA clearance | 18 / 18 | 18 / 18 | 0 |
| HIPAA / SOC2 / BAA | 0 / 10 | 0 / 10 | 0 |
| EHR integrations (count) | 0 / 4.2 | 0 / 4.2 | 0 |
| Top-3 EHR coverage (Epic / Oracle / Athena) | 0 / 2.4 | 0 / 2.4 | 0 |
| Peer-reviewed papers | 18.2 / 18.2 | 12.7 / 18.2 | +5.5 |
| RCT / meta-analysis / systematic review | 0 / 7.8 | 7.8 / 7.8 | -7.8 |
| Funding & adoption signal | 8.4 / 12 | 3 / 12 | +5.4 |
| Pricing transparency | 2.5 / 5 | 2.5 / 5 | 0 |
| Years in market | 6 / 6 | 0 / 6 | +6 |
Scroll horizontally to see every column.
Pricing
Brainomix
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. |
Clarius
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price verified. |
Evidence
Brainomix
FDA decisions
K260406 (opens in new tab)510(k)2026-06-12
Brainomix 360 Hyperdensity
K251983 (opens in new tab)510(k)2025-08-26
Brainomix 360 Triage Stroke
K242411 (opens in new tab)510(k)2025-02-19
Brainomix 360 e-Lung
K243294 (opens in new tab)510(k)2025-02-14
Brainomix 360 e-ASPECTS
K242123 (opens in new tab)510(k)2025-01-06
Brainomix 360 e-CTA
Show 8 more
K233875 (opens in new tab)510(k)2024-05-13
Brainomix 360 e-Lung
K232496 (opens in new tab)510(k)2023-11-21
Brainomix 360 Triage Stroke
K231837 (opens in new tab)510(k)2023-09-28
Brainomix 360 Triage LVO
K231656 (opens in new tab)510(k)2023-08-30
Brainomix 360 e-MRI
K231195 (opens in new tab)510(k)2023-07-27
Brainomix 360 Triage ICH
K223555 (opens in new tab)510(k)2023-06-01
Brainomix 360 e-CTP
K221564 (opens in new tab)510(k)2023-02-23
Brainomix 360 e-ASPECTS
K192692 (opens in new tab)510(k)2020-05-28
Brainomix 360 e-CTA
Peer-reviewed
5 PubMed records name Brainomix.
- Transforming Stroke Diagnosis with Artificial Intelligence: A Scoping Review of Brainomix e-Stroke, Aidoc, RapidAI, and Viz.ai. (opens in new tab)
- Real world clinical experience of using Brainomix e-CTA software in a medium size acute National Health Service Trust. (opens in new tab)
- Assessing the eligibility of Brainomix e-ASPECTS for acute stroke imaging. (opens in new tab)
Clarius
FDA decisions
K253593 (opens in new tab)510(k)2026-03-02
Clarius Ejection Fraction AI
K250226 (opens in new tab)510(k)2025-05-08
Clarius Median Nerve AI
K243853 (opens in new tab)510(k)2025-04-16
Clarius Prostate AI
K233955 (opens in new tab)510(k)2024-06-14
Clarius OB AI
K232257 (opens in new tab)510(k)2023-11-13
Clarius Bladder AI
Show 1 more
K222406 (opens in new tab)510(k)2023-01-23
Clarius AI
Peer-reviewed
3 PubMed records name Clarius.
- Can handheld ultrasound probes reliably measure transabdominal prostate and bladder volumes? A prospective randomized point-of-care ultrasound study. (opens in new tab)
- Artificial Intelligence-Assisted Lung Ultrasound for Pneumothorax: Diagnostic Accuracy Compared with CT in Emergency and Critical Care. (opens in new tab)
- 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)
Compliance and integrations
Documented from each vendor’s own pages.
| Spec | Brainomix | Clarius |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | 2012 | n/a |
| HQ | GB | n/a |
Scroll horizontally to see both columns.
Common questions
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