Heartflow

The computation is the product and always has been. FFRCT derives lesion-specific physiology from an already-acquired CCTA using computational fluid dynamics and AI, producing information that cannot be obtained from the scan by inspection and that otherwise requires an invasive catheter procedure. The company describes Heartflow One as an AI-driven platform across all four functions. No hardware and no services business underneath.

Decision support delivered as an analysis a clinician interprets and acts on, and the company frames its value as informing management decisions rather than making them. SMART-CT reporting improved inter-reader agreement and increased reader confidence while maintaining diagnostic accuracy, which is the right way to characterise an augmentation tool. Graded B rather than A because Heartflow's FFRCT workflow has historically involved a processing turnaround with vendor-side quality control, and the extent of any human step in that pipeline is not disclosed in retrieved materials, the same gap flagged on Elucid.

The four functions are clearly delineated and their intended uses distinguished, and the underlying approach has been described across a very large peer reviewed literature, so the methods are checkable in principle. Graded B rather than A for a specific and documented reason: when the Nature Reviews Cardiology QCI Study Group ran a head-to-head comparison of eight FDA-approved plaque quantification systems, the publication states Heartflow was unable to provide the required analysis for inclusion. Publishing extensively about your own product is not the same as submitting it for direct third-party comparison against competitors. Contrast Lunit, which earned an A partly for entering third-party head-to-head benchmarking twice.

The deepest evidence base of any vendor in this index, and it spans diagnostic accuracy, prognosis, workflow and economics rather than accuracy alone. More than 600 peer reviewed publications, over 100 studies covering more than 365,000 patients, and clinical use in over 400,000 patients. SCOT-HEART randomised 4,146 patients and found CCTA reduced coronary heart disease death or nonfatal MI by 41 percent at five years versus standard care, with post-hoc quantitative plaque analysis showing high total plaque volume associated with sevenfold greater MI risk. ADVANCE-DK reported seven year outcomes where normal FFRCT carried 5.7 percent adverse event risk versus 16.2 percent for abnormal, with plaque quantification improving predictive accuracy from AUC 0.63 to 0.73. SMART-CT measured a 25 percent reduction in read times. The Mass General Brigham CCTA registry tracked over 15,000 patients with up to 16 years of follow up. DECIDE is a roughly 22,000 patient registry across more than 30 US centres whose primary endpoint is change in medical management, which tests whether the tool changes what clinicians actually do rather than only what they see. NAVIGATE-PCI extends this to intervention planning. Crucially the guideline recognition is the strongest single marker: FFRCT is supported by the ACC/AHA Chest Pain Guideline, a higher bar than clearance and one no competitor in this lane holds.

Scans are transmitted to Heartflow for processing, making data handling material, but no published PHI retention, de-identification or model training policy was located at the time of review.

No published BAA terms located at the time of review, notable for a company operating at this scale across many health systems.

No specific third party attestation such as SOC 2 Type II, ISO 27001 or ISO 13485 was retrieved at the time of review, despite the company being publicly listed and operating internationally.

The strongest regulatory position in the cardiovascular CT lane, on two counts. First, breadth: all four functions cleared in the US, with Plaque Analysis and RoadMap cleared October 2022 and two further clearances reported May 2026. Second and more important, FFRCT is supported by the ACC/AHA Chest Pain Guideline. Guideline inclusion is a different and higher order of endorsement than a 510(k), because it reflects a professional society judging the evidence sufficient to shape recommended practice, and it is the reason this vendor sits apart from newer entrants with equivalent clearances. GEOGRAPHIC SCOPING BUYERS MUST CATCH, and the company does state it plainly: all four functions are cleared in the US, Bahrain, Israel, Saudi Arabia and the UAE, but ONLY FFRCT and Planner are cleared in Europe, the UK, Australia, Canada and Japan. Plaque Analysis and RoadMap are not available for clinical use across most of the developed world outside the US, which inverts the usual pattern where European CE marking precedes FDA clearance.

No demographic subgroup performance analysis was located despite an evidence base spanning hundreds of thousands of patients, which makes the omission more conspicuous here than for smaller vendors. With registries of this size, including Mass General Brigham at over 15,000 patients and DECIDE at roughly 22,000, subgroup analysis by sex, race and age is entirely feasible and would be highly informative. Sex differences in coronary artery disease presentation and in plaque composition are well documented, making this a substantive rather than procedural gap.

No named PACS, RIS or EHR integration list was retrieved at the time of review. Given deployment across hundreds of health systems, integration capability clearly exists in practice, but no specific partner or interface disclosure was located to grade against.

Cloud service model: CCTA data is transmitted to Heartflow, analysed, and results returned into the clinical workflow, requiring no new scanner hardware or change to acquisition. That is a genuine adoption advantage and works on scans institutions already perform. Graded B rather than A because the model inherently means patient imaging leaves the institution, and no data residency terms or regional hosting arrangements were published, which matters given clearances across multiple jurisdictions with differing data regimes.

No list price published, but the reimbursement position is documented more thoroughly than almost any vendor in the index, and the company publishes a market access value dossier addressing it directly. Plaque Analysis received an EviCore coverage recommendation in July 2025, CMS began reimbursing plaque analysis as a separate outpatient hospital service, and automated plaque analysis carries an established Category I CPT pathway. Notably the company's own dossier states candidly that current reimbursement does not provide adequate payment for FFRCT, an unusually frank admission against interest. Heartflow has also published cost-effectiveness analysis, including at AHA 2025, and reported significant cost savings across analyses of over 90,000 patients. Graded B rather than A because per-analysis pricing to the institution is not disclosed.

Within cardiovascular care the coverage is the broadest in the lane, spanning the full CCTA pathway from screening and risk stratification through diagnosis, physiological assessment, medical management and now CT-guided PCI planning via Planner and the NAVIGATE-PCI registry. No competitor covers that span. Graded B rather than A because it remains a single disease domain, coronary artery disease, serving cardiology and cardiac imaging, and is graded on the same scale as index vendors covering multiple body systems and specialties.