Circle Cardiovascular Imaging vs Iterative Health
A GI endoscopy unit is SKOUT's buyer, and a cardiac CT lab is Circle's, because SKOUT reads colonoscopy video and cvi42 reads CT and MR.
SKOUT has a randomized trial behind it, run by the sponsor, with 22 endoscopists at 5 centers and 677 standard versus 682 CADe colonoscopies. Adenomas per colonoscopy rose from 0.83 to 1.05 (P=.002), while adenoma detection rate moved from 43.9% to 47.8% (P=.065, not significant). The device has six clearances, from K213686 on August 12, 2022 to K253664 on December 22, 2025.
Circle calls itself Canadian-based and founded in 2007. PubMed returns 133 results for cvi42, overwhelmingly research papers that use it as the measurement tool and not validations of it. Circle's price is not public.
Iterative Health's home page now leads with clinical research, though SKOUT keeps its own product page, where the call to action is a demo.
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.
Iterative Health
by Iterative Health · founded 2017
Real-time AI polyp detection for colonoscopy with the FDA-cleared SKOUT system, for endoscopists and endoscopy centers.
When to pick each one
Circle Cardiovascular Imaging
- Canadian vendor, founded in 2007
- Cardiac MR and CT analysis, stroke CT tools
- cvi42 used as a measurement tool in research papers
Iterative Health
- SKOUT real-time polyp detection on colonoscopy video
- Sponsor-run randomized trial, 22 endoscopists at 5 centers
- Six 510(k)s under product code QNP
Score
Each row shows points earned of points available under the published rubric.
Circle Cardiovascular Imaging
42of 100
Iterative Health
42of 100
| Dimension | Circle Cardiovascular Imaging | Iterative Health | 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 | 0 / 18.2 | 0 |
| RCT / meta-analysis / systematic review | 0 / 7.8 | 0 / 7.8 | 0 |
| Funding & adoption signal | 8.4 / 12 | 8.4 / 12 | 0 |
| Pricing transparency | 2.5 / 5 | 2.5 / 5 | 0 |
| Years in market | 6 / 6 | 6 / 6 | 0 |
Scroll horizontally to see every column.
Pricing
Circle Cardiovascular Imaging
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. |
Iterative Health
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. Demo request only. |
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
Iterative Health
FDA decisions
K253664 (opens in new tab)510(k)2025-12-22
SKOUT system
K251126 (opens in new tab)510(k)2025-05-09
SKOUT system
K241508 (opens in new tab)510(k)2024-07-03
SKOUT system
K240781 (opens in new tab)510(k)2024-04-19
SKOUT system
K230658 (opens in new tab)510(k)2023-04-07
SKOUT system
Show 1 more
K213686 (opens in new tab)510(k)2022-08-12
SKOUT Software
Compliance and integrations
Documented from each vendor’s own pages.
| Spec | Circle Cardiovascular Imaging | Iterative Health |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | 2007 | 2017 |
| HQ | CA | US |
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.