Imaging & Diagnostic AI · Assurance Record
Viz.ai One Platform
Viz.ai · Hospital (ED, stroke and cardiac units); ambulatory/outpatient research sites · Cloud SaaS; HL7/DICOM integration with PACS and EHR; secure mobile alerting for care teams
Decision summary
- Suitable for
- Acute-care hospitals and health systems, comprehensive stroke centers, neurovascular and cardiology departments
- 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
- 1 of 3 evidence claims independently confirmed · confidence Moderate
- Critical unknowns
- No critical documentary gaps identified
- Last independent review
- 2026-08-27
regulatory filingFDA granted the first-ever De Novo clearance for an AI computer-aided triage and notification platform (Viz LVO, Feb 2018), creating a new r…2018-02-14
Exact claim. FDA granted the first-ever De Novo clearance for an AI computer-aided triage and notification platform (Viz LVO, Feb 2018), creating a new regulatory classification for AI triage software
- Source
- fda.gov
- Type
- regulatory filing
- Published
- 2018-02-14
- 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 fda.govindependent reportDeployed across nearly 2,000 U.S. hospitals covering 230M+ lives as of late 2025 (up from 1,000+ hospitals in 2024); ~$291.5M total funding …2025-11-30
Exact claim. Deployed across nearly 2,000 U.S. hospitals covering 230M+ lives as of late 2025 (up from 1,000+ hospitals in 2024); ~$291.5M total funding at a $1.2B valuation
- Source
- sacra.com
- Type
- independent report
- Published
- 2025-11-30
- Retrieved
- 2026-08-27
- Verification
- excerpt_matched
- Confidence
- not stated
- Reviewer
- healthit-gate-v1
- Claim version
- v1
- Supports
- deployment_traction
- Score contribution
- Feeds deployment traction
Independent source. Methodology and sample vary by report; read the underlying method.
Open sacra.compress releaseCompleted SOC 2 Type II and HIPAA audits for the Viz.ai One Platform, marking the fourth consecutive year of SOC 2 Type II compliance2024-02-26
Exact claim. Completed SOC 2 Type II and HIPAA audits for the Viz.ai One Platform, marking the fourth consecutive year of SOC 2 Type II compliance
- Source
- viz.ai
- Type
- press release
- Published
- 2024-02-26
- Retrieved
- 2026-08-27
- Verification
- unverified
- Confidence
- not stated
- Reviewer
- healthit-gate-v1
- Claim version
- v1
- Supports
- trust_governance
- Score contribution
- Feeds trust governance
Vendor or press announcement. Verify material claims against primary filings or contracts.
Open viz.aiVerified 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
- Epic, Cerner
- 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
- Processes PHI in HIPAA-compliant cloud; SOC 2 Type II controls; HIPAA audit program · BAA available
- Security attestations
- SOC 2 Type II, 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
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
- 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.