Cleerly vs HeartFlow
Heartflow has the longer record in CT-derived fractional flow reserve. Its first FFRct clearance was a De Novo in November 2014, and per its 10-K FFRct made up 98% of 2025 revenue of $176.0 million. The company trades on Nasdaq as HTFL, bills pay-per-use, and reports 489 U.S. accounts for Plaque Analysis at the end of 2025 (K213857, October 2022).
Cleerly's ischemia module arrived as a 510(k) in September 2023. Cleerly says its CREDENCE-based result beat FFRCT on accuracy against 868 invasive FFR measurements, which is a vendor claim. Cleerly also lists PowerScribe integration, serial scan comparison and CPT 75577 coverage, including Aetna as of January 2026.
Plaque phenotype, stenosis and ischemia in one platform is Cleerly's pitch. A chest pain service built around FFR-CT and the longest regulatory record leans Heartflow, and Cleerly trails for it.
Radiology · Reviewed November 1, 2026
When to pick each one
Cleerly
- Plaque phenotype, stenosis and ischemia likelihood in one platform
- PowerScribe integration and serial scan comparison
HeartFlow
- FFRct first cleared in 2014, De Novo DEN130045
- Plaque Analysis and Roadmap Analysis alongside FFRct
Score
Each row shows points earned of points available under the published rubric.
Cleerly
52of 100
HeartFlow
66of 100
| Dimension | Cleerly | HeartFlow | 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 | 12.7 / 18.2 | 12.7 / 18.2 | 0 |
| RCT / meta-analysis / systematic review | 3.9 / 7.8 | 7.8 / 7.8 | -3.9 |
| Funding & adoption signal | 6 / 12 | 8.4 / 12 | -2.4 |
| Pricing transparency | 2.5 / 5 | 2.5 / 5 | 0 |
| Years in market | 0 / 6 | 6 / 6 | -6 |
Scroll horizontally to see every column.
Pricing
Cleerly
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. The homepage offers a demo request. |
HeartFlow
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Per study | n/a | n/a | No public list price. The 10-K describes revenue as pay-per-use. |
Evidence
Cleerly
FDA decisions
K260588 (opens in new tab)510(k)2026-07-29
Cleerly LABS
K261210 (opens in new tab)510(k)2026-07-29
Cleerly Plaque
K242338 (opens in new tab)510(k)2025-03-07
Cleerly LABS (v2.0)
K231335 (opens in new tab)510(k)2023-09-08
Cleerly ISCHEMIA
K202280 (opens in new tab)510(k)2020-10-02
Cleerly Labs v2.0
Show 1 more
K190868 (opens in new tab)510(k)2019-11-05
Cleerly Labs
Peer-reviewed
2 PubMed records name Cleerly.
HeartFlow
FDA decisions
K250902 (opens in new tab)510(k)2025-07-18
HeartFlow Analysis
K213857 (opens in new tab)510(k)2022-10-14
HeartFlow Analysis
K203329 (opens in new tab)510(k)2021-01-08
HeartFlow Analysis
K190925 (opens in new tab)510(k)2019-08-15
K182035 (opens in new tab)510(k)2018-12-06
Show 3 more
K161772 (opens in new tab)510(k)2016-08-24
K152733 (opens in new tab)510(k)2016-01-13
DEN130045 (opens in new tab)De Novo2014-11-26
FFRct
Peer-reviewed
2 PubMed records name HeartFlow.
- Prognostic value of CT-derived fractional flow reserve for major adverse cardiovascular events in patients with suspected or known coronary artery disease: a systematic review and meta-analysis. (opens in new tab)
- Diagnostic Performance of AI-enabled Plaque Quantification from Coronary CT Angiography Compared with Intravascular Ultrasound. (opens in new tab)
Compliance and integrations
Documented from each vendor’s own pages.
| Spec | Cleerly | HeartFlow |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | n/a | 2007 |
| HQ | US | 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.