EchoNous vs HeartFlow
HeartFlow sells to hospitals with coronary CT angiography volume. Its service estimates fractional flow reserve and quantifies plaque from a coronary CT angiogram processed in the vendor's cloud. Its first FFRct decision was a De Novo in November 2014. The company went public in August 2025, reported 2025 revenue of $176.0 million with FFRct at 98% of it, and describes revenue as pay-per-use. A total of 489 US accounts used Plaque Analysis at the end of 2025.
EchoNous builds Kosmos, a handheld echo device for clinicians who scan at the bedside. It reports automated ejection fraction, stroke volume and cardiac output. PANES-HF, a 2024 Scientific Reports study, looked at point-of-care AI-enhanced novice echocardiography for heart failure screening. openFDA lists four Kosmos clearances from March 2020 to April 2025.
The two start from different scans, a coronary CT angiogram in one case and a probe on the chest in the other. Hospitals with CT volume buy HeartFlow, and point-of-care cardiac users buy Kosmos.
Radiology · Reviewed November 2, 2026
When to pick each one
EchoNous
- Automated ejection fraction on a handheld device
- Four Kosmos 510(k)s from 2020 to 2025
HeartFlow
- CT-derived FFR from a coronary CT angiogram
- Public company, Nasdaq HTFL
- Pay-per-use revenue model
Score
Each row shows points earned of points available under the published rubric.
EchoNous
78of 100
HeartFlow
66of 100
| Dimension | EchoNous | HeartFlow | Difference |
|---|---|---|---|
| FDA clearance | 18 / 18 | 18 / 18 | 0 |
| HIPAA / SOC2 / BAA | 10 / 10 | 0 / 10 | +10 |
| 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 | 7.8 / 7.8 | 7.8 / 7.8 | 0 |
| Funding & adoption signal | 3 / 12 | 8.4 / 12 | -5.4 |
| Pricing transparency | 2.5 / 5 | 2.5 / 5 | 0 |
| Years in market | 6 / 6 | 6 / 6 | 0 |
Scroll horizontally to see every column.
Pricing
EchoNous
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. The vendor says Kosmos Plus costs less than $20k. |
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
EchoNous
FDA decisions
K242321 (opens in new tab)510(k)2025-04-25
Kosmos
K233826 (opens in new tab)510(k)2024-08-29
Kosmos
K212100 (opens in new tab)510(k)2021-08-06
Kosmos
K193518 (opens in new tab)510(k)2020-03-26
KOSMOS
Peer-reviewed
5 PubMed records name EchoNous.
- Army Medic Performance in Trauma Sonography: The Impact of Artificial Intelligence Assistance in Focused Assessments With Sonography in Trauma-A Prospective Randomized Controlled Trial. (opens in new tab)
- Point-of-care AI-enhanced novice echocardiography for screening heart failure (PANES-HF). (opens in new tab)
- Validation of a hand-held ultrasound device in the evaluation of aortic stenosis. (opens in new tab)
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 | EchoNous | HeartFlow |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | 2016 | 2007 |
| HQ | US | US |
Scroll horizontally to see both columns.
Common questions
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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.