Circle Cardiovascular Imaging vs Clarius
Six of Clarius's twelve FDA records are AI-named: Clarius AI, Bladder AI, OB AI, Prostate AI, Median Nerve AI and, since March 2026, Ejection Fraction AI. The scanners are wireless, with a phone or tablet as the display, and the vendor's AI page marks several tools "Available in select markets". The home page routes buyers to online stores and a quote form.
Circle's cvi42 analyses studies that MR and CT scanners have already produced. Its openFDA record includes CMR42 in 2008, myocardial strain software (K232661, December 2023), cardiac CT function software (K241038, June 2024) and coronary plaque software (K251027, October 2025), and the company says it was founded in 2007.
A cardiology office scanning at the point of care and a hospital reading cardiac MR are different buyers. The first gets ejection fraction from a live Clarius probe, and the second gets volumes and strain from stored MR and CT studies in Circle.
Radiology · Reviewed November 2, 2026
Circle Cardiovascular Imaging
by Circle Cardiovascular Imaging Inc. · founded 2007
cvi42 cardiac MR and CT software with FDA-cleared AI coronary plaque analysis and StrokeSENS acute stroke tools.
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
Circle Cardiovascular Imaging
- Cardiac MR and CT volumes, strain and mapping
- Strain software cleared December 2023
- 12 FDA records, including two stroke tools
Clarius
- Ejection Fraction AI cleared March 2026
- Bladder, prostate, OB and median nerve AI
- Phone or tablet serves as the display
Score
Each row shows points earned of points available under the published rubric.
Circle Cardiovascular Imaging
42of 100
Clarius
53of 100
| Dimension | Circle Cardiovascular Imaging | 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 | 0 / 18.2 | 12.7 / 18.2 | -12.7 |
| 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
Circle Cardiovascular Imaging
| 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
Circle Cardiovascular Imaging
FDA decisions
K251027 (opens in new tab)510(k)2025-10-27
cvi42 Coronary Plaque Software Application
K250221 (opens in new tab)510(k)2025-07-01
StrokeSENS ASPECTS Software Application
K242781 (opens in new tab)510(k)2024-10-15
cvi42 Software Application
K241038 (opens in new tab)510(k)2024-06-07
Cardiac CT Function Software Application
K232661 (opens in new tab)510(k)2023-12-07
Myocardial Strain Software Application
Show 7 more
K222593 (opens in new tab)510(k)2023-01-18
TruPlan Computed Tomography Imaging Software
K213998 (opens in new tab)510(k)2022-07-28
cvi42 Auto Imaging Software Application
K212261 (opens in new tab)510(k)2021-10-14
StrokeSENS LVO
K202212 (opens in new tab)510(k)2021-02-19
TruPlan
K141480 (opens in new tab)510(k)2014-08-22
CVI42
K111373 (opens in new tab)510(k)2011-08-23
CT42 Cardiac CT Software
K082628 (opens in new tab)510(k)2008-11-20
CMR42 Cardiac MRI Imaging System
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 | Circle Cardiovascular Imaging | Clarius |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | 2007 | n/a |
| HQ | CA | n/a |
Scroll horizontally to see both columns.
Common questions
Open the full radiology comparison
Acute-care triage, mammography screening, CCTA plaque analysis, mobile MRI. 30+ FDA-cleared platforms across stroke, oncology, cardiac. Enterprise sales only — we compared what's deployed where.