Imaging & Diagnostic AI · Assurance Record
HeartFlow Analysis (FFRct)
HeartFlow · Outpatient/ambulatory cardiac imaging; hospital cardiology · Cloud SaaS analysis service; DICOM upload with results returned to site; AWS infrastructure
Decision summary
- Suitable for
- Cardiology departments, health systems, outpatient cardiac imaging centers, payers
- Documentary gate
- Failed
- Scenario match
- Matches this scenario — FDA-cleared imaging AI platforms
- Comparability
- Not yet comparable in this scenario
- Decision readiness
- HISTORICAL — Research only
- Documented evidence
- 2 of 4 evidence claims independently confirmed · confidence Low
- Critical unknowns
- No critical documentary gaps identified
- Last independent review
- 2026-08-27
press 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.govpress 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.compeer 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 (not a 0–100 rank)
Deployment, integration, data handling
- 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_8a8a4c9bb810aee3 · 2026-08-27T04:05Z · build 6a9fe1b
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.