HeartFlow Analysis (FFRct)
HeartFlow · Outpatient/ambulatory cardiac imaging; hospital cardiology · Cloud SaaS analysis service; DICOM upload with results returned to site; AWS infrastructure
Imaging & Diagnostic AI
Cloud-based AI analysis of coronary CTA that computes FFRct (fractional flow reserve from CT), plaque characterization and PCI planning (Roadmap) to guide coronary artery disease management without invasive catheterization. FDA-cleared, supported by 625+ peer-reviewed publications and used to manage 650,000+ patients across 1,800+ institutions.
Evidence at a glance
Freshness, source-checked counts, confidence and gate results below reflect the frozen evidence snapshot through . A later editorial review does not update these results.
- Stated intended users
- Cardiology departments, health systems, outpatient cardiac imaging centers, payers
- Documentary gate at snapshot
- Failed
- Scenario match
- Outside this scenario — FDA-cleared imaging AI platforms
- Comparability
- Not yet comparable in this scenario
- Decision readiness at snapshot
- HISTORICAL — Research only
- Documented evidence at snapshot
- 2 of 4 evidence claims source-checked · confidence Low
- Critical unknowns
- No critical documentary gaps identified
- Latest checked-source retrieval in snapshot
- 2026-08-27
Expand each claim to inspect its source, dates and recorded verification status.
press releaseReceived FDA 510(k) clearance and launched the next-generation HeartFlow Plaque Analysis platform in September 20252025-09-22
Exact claim. Received FDA 510(k) clearance and launched the next-generation HeartFlow Plaque Analysis platform in September 2025
- Source
- ir.heartflow.com
- Type
- press release
- Published
- 2025-09-22
- Retrieved
- 2026-08-27
- Verification
- excerpt_matched
- Confidence
- not stated
- Reviewer
- healthit-gate-v1
- Claim version
- v1
- Supports
- evidence_strength
- Score contribution
- Feeds evidence strength
Vendor or press announcement. Verify material claims against primary filings or contracts.
Open ir.heartflow.compress releaseCompleted an upsized IPO on Nasdaq (HTFL) raising ~$364.2M in gross proceeds at $19/share; shares began trading Aug 8, 20252025-08-11
Exact claim. Completed an upsized IPO on Nasdaq (HTFL) raising ~$364.2M in gross proceeds at $19/share; shares began trading Aug 8, 2025
- Source
- ir.heartflow.com
- Type
- press release
- Published
- 2025-08-11
- Retrieved
- 2026-08-27
- Verification
- excerpt_matched
- Confidence
- not stated
- Reviewer
- healthit-gate-v1
- Claim version
- v1
- Supports
- market_durability
- Score contribution
- Feeds market durability
Vendor or press announcement. Verify material claims against primary filings or contracts.
Open ir.heartflow.comregulatory filingHeartFlow Analysis (FFRct) cleared via 510(k) K213857 on Oct 14, 2022 as an AI-based coronary vascular physiologic simulation software devic…2022-10-14
Exact claim. HeartFlow Analysis (FFRct) cleared via 510(k) K213857 on Oct 14, 2022 as an AI-based coronary vascular physiologic simulation software device (Class II, product code PJA)
- Source
- accessdata.fda.gov
- Type
- regulatory filing
- Published
- 2022-10-14
- Retrieved
- 2026-08-27
- Verification
- unverified
- Confidence
- not stated
- Reviewer
- healthit-gate-v1
- Claim version
- v1
- Supports
- evidence_strength
- Score contribution
- Feeds evidence strength
A regulatory listing confirms authorization status — not real-world effectiveness or economics.
Open accessdata.fda.govpeer reviewed studyPLATFORM trial (JACC 2015): in 584 patients with suspected coronary disease, FFRCT-guided care reduced mean total medical costs by 32% in th…2015-12-01
Exact claim. PLATFORM trial (JACC 2015): in 584 patients with suspected coronary disease, FFRCT-guided care reduced mean total medical costs by 32% in the planned-invasive stratum versus usual care ($7,343 vs $10,734; p<0.0001) over 90-day follow-up.
- Source
- doi.org
- Type
- peer reviewed study
- Published
- 2015-12-01
- Retrieved
- 2026-08-27
- Verification
- unverified
- Confidence
- not stated
- Reviewer
- healthit-gate-v1
- Claim version
- v1
- Supports
- evidence_strength
- Score contribution
- Feeds evidence strength
Peer-reviewed. Check population, setting, and applicability to your workflow before generalizing.
Open doi.orgVerified provider experience is not yet publishable. Fewer than five independent provider organizations have contributed eligible reviews. Reviewer mode is off. Experience never changes documentary scoring, freshness, or rank.
Buyer lenses — evidence-backed bands at snapshot (not a 0–100 rank)
Deployment, integration, data handling at snapshot
- Integration maturity
- announced — Announced or documented integration; marketplace listing not confirmed.
- EHR path
- UNKNOWN
Why unknown
Why. No reliable source on file. The platform does not infer values from weak sources.
What would close it. A primary source or independent verification.
- FHIR / API
- UNKNOWN
Why unknown
Why. No reliable source on file. The platform does not infer values from weak sources.
What would close it. A primary source or independent verification.
- SSO
- UNKNOWN
Why unknown
Why. Single-sign-on support is not documented in vendor or marketplace materials on file.
What would close it. Vendor security documentation or marketplace listing mentioning SSO/SAML/OIDC.
- PHI / BAA
- PHI processed in HIPAA/HITRUST-compliant cloud; encryption at rest and in transit · BAA available
- Security attestations
- SOC 2 Type II, HITRUST, ISO/IEC 27001:2022, ISO 13485:2016, HIPAA
- FDA status
- UNKNOWN
Why unknown
Why. No FDA listing found for this product's functions in the tracked category.
What would close it. An FDA 510(k)/De Novo listing, or a clear statement that no regulated function is claimed.
- Pricing
- Not publicly listed (per-study pricing); CMS APC 5724 reimbursement ~$1,017 (CY2025) and reported UK list price ~£700/test in NICE documentation per FitGap
Technical provenance
snap_36bba25c577cbb44 · Evidence cutoff: 2026-08-27T04:05Z · Snapshot generated: 2026-10-21T19:39Z · build ffbf5c3
Forecast calibration is not in the public snapshot — shown as UNKNOWN rather than read from SQLite.
Known limitations
- Deployment traction is UNKNOWN.
Why unknown
Why. No reliable source on file. The platform does not infer values from weak sources.
What would close it. A primary source or independent verification.
- Interoperability is UNKNOWN.
Why unknown
Why. No reliable source on file. The platform does not infer values from weak sources.
What would close it. A primary source or independent verification.
- Economic value evidence is UNKNOWN.
Why unknown
Why. No independently verifiable ROI claim (peer-reviewed, audited case, or independent benchmark) is on file.
What would close it. An audited implementation report or peer-reviewed study with payback/throughput numbers.