- No public list price. The 10-K describes revenue as pay-per-use.
- Not disclosed
- Not disclosed
- —
- 2007
- US
Radiology
HeartFlow
by HeartFlow · founded 2007 · US
Coronary CT angiogram analysis: CT-derived fractional flow reserve (FFRct), plaque analysis and a CCTA reading aid.
On this page
54/100Solid choice
- Regulatory & Compliance18/28
FDA cleared (8 K-numbers on record)
- Clinical Integration0/26
No EHR integrations listed
- Evidence Strength26/26
5 peer-reviewed papers
- Vendor & Market14.4/18
Mid-tier funding and adoption
- Sentiment & Transparency2.5/14
Pricing on request, no public amounts
▸ Show all 11 dimensions▾ Hide dimension detail
- FDA clearance18/18
FDA cleared (8 K-numbers on record)
- HIPAA / SOC2 / BAA0/10
No public HIPAA/SOC2/BAA attestation
- EHR integrations (count)0/14
No EHR integrations listed
- Top-3 EHR coverage (Epic / Oracle / Athena)0/8
None of the top-3 EHRs covered
- Bidirectional write-back0/4
No bidirectional write-back documented
- Peer-reviewed papers18/18
5 peer-reviewed papers
- RCT / meta-analysis / systematic review8/8
1 RCT/Meta-Analysis/Systematic Review
- Funding & adoption signal8/12
Mid-tier funding and adoption
- Years in market6/6
Founded 2007 (19 years)
- Clinician sentiment (Reddit)0/9
No clinician sentiment data available
- Pricing transparency3/5
Pricing on request, no public amounts
Non-invasive CCTA-derived FFR, reimbursable since CPT 75577 (Jan 2026).
Most clinical-evidence-backed CCTA AI. IPO filed 2026. Eliminates invasive angiography for many patients.
Bottom line
Heartflow turns a coronary CT angiogram into a computed fractional flow reserve, a plaque quantification and a standardized read, all processed in the vendor's cloud and billed per study. It fits cardiology and radiology programs that already run CCTA and want a noninvasive way to decide who needs the cath lab. It is a poor fit for a practice without CT.
What is Heartflow and who sells it?
Heartflow, Inc. is based in Mountain View, California, with offices in Santa Rosa, San Francisco, Austin and Tokyo. It was incorporated in Delaware in July 2007 as Cardiovascular Simulation, per its FY2025 10-K, and it trades on Nasdaq as HTFL. The IPO priced on August 7, 2025 at $19 per share, and the upsized offering of 19,166,667 shares raised about $364.2 million gross.
Revenue was $176.0 million in 2025, up from $125.8 million in 2024 and $87.2 million in 2023. FFRct accounted for 98 percent of it. At the time of the 10-K, 2026 guidance was $218 to $222 million.
What does it do?
The homepage lists three analyses. FFRct Analysis computes blood flow anywhere in the coronary tree from a CCTA and, in the vendor's words, helps determine the benefit of revascularization. Plaque Analysis quantifies and characterizes plaque to inform risk. Roadmap Analysis aims for consistent reads of every CCTA across readers. Plaque Staging and PCI Navigator appear in the site navigation without description.
Vendor figures on the homepage include more than 750,000 patients, more than 1,800 institutions, more than 625 peer-reviewed publications and coverage of 99.5 percent of US lives. None comes with a source. The 10-K reports 489 US accounts using Plaque Analysis at the end of 2025.
What is the FDA status?
The first FFRct authorization was a De Novo, DEN130045, decided on November 26, 2014. Six later 510(k) clearances for applicant HeartFlow appear in the FDA database, from K152733 in January 2016 to K250902 in July 2025. K213857, from October 2022, matches the 10-K's Plaque Analysis clearance. The vendor announced a next-generation platform with a 510(k) clearance on September 22, 2025.
The CE Mark for FFRct dates from July 2011 per the 10-K. Heartflow does not state MDR or IVDR status, so Europe-based buyers should ask for the certificate. The homepage shows an ISO 13485 logo. HIPAA, SOC 2 and EHR integrations are not stated, and availability is the United States plus specific functionality in the EU, UK, Japan, Canada and some other regions.
What does the evidence say?
A 2026 meta-analysis in Open Heart found CT-derived fractional flow reserve prognostic for major adverse cardiac events. It covers the technique as a class and does not isolate Heartflow. A 2024 study in Radiology: Cardiothoracic Imaging compared AI plaque quantification from CCTA with intravascular ultrasound and names Heartflow. Three other 2025 papers are general reviews of AI in cardiovascular imaging and say little about the product.
What does it cost?
Heartflow publishes no price. The 10-K says substantially all revenue is pay-per-click, meaning per analysis. The homepage links a reimbursement section without listing CPT codes, and the hospital price per study is not public.
Who is it for?
A cardiology group with a busy CCTA service is the natural customer, because the vendor positions FFRct as a way to judge the benefit of revascularization. A radiology department that wants consistent plaque reporting across readers can look at Plaque and Roadmap Analysis. A clinic that refers every CT out has no use for it, since the product sits inside the CT workflow.
The verdict
Cardiology and radiology programs with an established CCTA service should evaluate Heartflow. Ask for the per-study price, and for the outcome data behind the plaque products before paying for them.
Editorial review last generated October 15, 2026. Synthesized from clinician sentiment, peer-reviewed coverage, and our editorial silo picks. Refined by hand where vendor facts change.
What it costs
All tiers are custom-quoted. The vendor does not publish per-provider list pricing.
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Per study | — | — | No public list price. The 10-K describes revenue as pay-per-use. |
Source: vendor pricing page. Last checked October 15, 2026.
What deploys cleanly
Carries FDA De Novo, FDA 510(k), CE Mark (FFRct Analysis, 2011) per vendor documentation. Independent attestation review is the buyer's responsibility before clinical deployment.
Who builds it
HeartFlow (HeartFlow) was founded in 2007 in US, putting it 19 years into market.
What the literature says
5 peer-reviewed studies indexed on PubMed evaluate HeartFlow in clinical contexts. The most relevant are shown below, ranked by editorial relevance score combining title match, study design, recency, and journal tier.
- 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.
- Biswas S, Srivastava Y, Hamadttu A· Open Heart· 2026
- Fractional flow reserve derived from CT (FFR-CT) enables non-invasive functional assessment of coronary stenoses in patients with suspected or known coronary artery disease, but evidence regarding its prognostic value remains fragmented. We conducted a systematic review and meta-analysis to quantify the association between abnormal FFR-CT and major adverse cardiovascular events (MACE), updating the 2022 meta-analysis by NørgaardMETHODS: We searched PubMed, Embase and Scopus through December 2025 for studies comparing outcomes in patients with suspected or known coronary artery disease wi…
- Diagnostic Performance of AI-enabled Plaque Quantification from Coronary CT Angiography Compared with Intravascular Ultrasound.
- Ihdayhid AR, Tzimas G, Peterson K, et al.· Radiol Cardiothorac Imaging· 2024
- Purpose To assess the diagnostic performance of a coronary CT angiography (CCTA) artificial intelligence (AI)-enabled tool (AI-QCPA; HeartFlow) to quantify plaque volume, as compared with intravascular US (IVUS). Materials and Methods A retrospective subanalysis of a single-center prospective registry study was conducted in participants with ST-elevation myocardial infarction treated with primary percutaneous coronary intervention of the culprit vessel. Participants with greater than 50% stenosis in nonculprit vessels underwent CCTA, invasive coronary angiography, and IVUS of nonculprit lesio…
- Artificial Intelligence in Cardiovascular Imaging: Current Landscape, Clinical Impact, and Future Directions.
- Edpuganti S, Shamim A, Gangolli VH, et al.· Discoveries (Craiova)· 2025
- Cardiovascular (CV) imaging is rapidly transforming with the advent of artificial intelligence (AI), automating and augmenting diagnostic pipelines in echocardiography, computed tomography (CT), magnetic resonance imaging (MRI), and nuclear imaging. In this review, we summarize recent developments in convolutional neural networks for real-time echocardiographic interpretation, deep learning for coronary artery calcium scoring that achieves near-perfect agreement with manual methods, and AI-driven plaque quantification and stenosis detection on coronary CT angiography, which achieves an accura…
- Reimagining chronic total occlusion management interventions: the role of artificial intelligence in imaging, planning, and procedural guidance.
- Padda I, Sebastian SA, Sethi Y, et al.· Int J Cardiovasc Imaging· 2025
- Chronic Total Occlusions (CTOs) remain among the most complex lesions encountered in percutaneous coronary intervention (PCI), presenting significant technical and clinical challenges due to ambiguous vessel anatomy, lesion heterogeneity, and high operator variability. Although recent advancements in interventional techniques have improved success rates, procedural outcomes remain variable. The integration of Artificial Intelligence (AI) into CTO management offers the potential to optimize each stage of care, including lesion assessment, procedural planning, real-time intra-procedural support…
- Harnessing Artificial Intelligence for Precision Cardiovascular Medicine.
- Banerjee A, Sarangi PK· Cureus· 2025
- Artificial intelligence (AI) has revolutionized cardiology diagnostic capabilities by improving precision, effectiveness, and prompt identification of various cardiac diseases. AI subfields include machine learning, deep learning, and cognitive computing. Machine learning can be supervised, unsupervised, or reinforcement learning. Support vector machines (SVM), deep learning, and artificial neural networks (ANN) are commonly used in the medical field for handling large and complex data. ANNs perform better than SVMs in evaluating electrocardiogram (ECG) data, while SVMs are used for disease s…
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