Brainomix vs HeartFlow
HeartFlow trades on Nasdaq as HTFL and reported $176.0 million in 2025 revenue, 98% of it from FFRct, with the 10-K describing revenue as pay-per-use. Its buyer is a cardiology program with a coronary CT angiography service that wants CT-derived fractional flow reserve and plaque analysis. Brainomix goes to stroke networks that read head CT, CTA, CTP and MRI.
HeartFlow's FDA history starts with De Novo DEN130045 in November 2014 and reaches HeartFlow Analysis K250902 in July 2025. The vendor claims more than 1,800 institutions. Brainomix has thirteen openFDA 510(k) records, from e-CTA in May 2020 to Hyperdensity in June 2026, and its triage modules for ICH, LVO and stroke carry product code QAS. The vendor reports 49 million pounds raised in private investment and public funding.
A hospital system running both a stroke service and a coronary CTA service would take HeartFlow for the cardiac scanner and Brainomix for the emergency pathway.
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.
HeartFlow
by HeartFlow · founded 2007
Coronary CT angiogram analysis: CT-derived fractional flow reserve (FFRct), plaque analysis and a CCTA reading aid.
When to pick each one
Brainomix
- Thirteen openFDA 510(k) records, latest June 2026
- Triage modules for ICH, LVO and stroke
HeartFlow
- CT-derived FFR and plaque analysis from coronary CTA
- Nasdaq-listed, $176.0M revenue in 2025
- De Novo DEN130045 in November 2014
Score
Each row shows points earned of points available under the published rubric.
Brainomix
64of 100
HeartFlow
66of 100
| Dimension | Brainomix | 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 | 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 | 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
Brainomix
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. |
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
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)
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 | Brainomix | HeartFlow |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | 2012 | 2007 |
| HQ | GB | 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.