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Monthly procurement notes on clinical AI categories, validation, compliance, and vendor changes.
FDA-listed AI-enabled medical device candidate for healthcare AI buyers.
Annalise Enterprise is a Phase 7 candidate from the FDA AI-enabled medical devices list. Maker: Harrison-AI Medical Technologies. Panel: Radiology. HealthAIdir lists it as a conditional seed profile pending deeper vendor evidence review.
Reliability of claims, output quality, and evidence fit.
Fit for clinical, revenue, or operations workflows.
HIPAA, PHI, BAA, and governance readiness signals.
Value relative to expected cost, onboarding, and effort.
Maturity, documentation, support, and market signals.
No public pricing source was found during the 2026-06-17 Phase 7 evidence pass; pricing remains unknown and should be confirmed with the vendor or an official pricing page.
Promote only after FDA database entry plus vendor product, pricing, privacy, security, and compliance pages are reviewed. Confirm workflow owner, integration path, clinical or administrative review steps, support model, and rollout controls before procurement.
HIPAA
Not reviewed
BAA
Not reviewed
Official evidence sources captured for review: regulatory/context https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices; regulatory/context https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253818. Treat HIPAA, BAA, SOC 2, HITRUST, FDA, MDR, and PHI handling claims as unconfirmed until the linked sources are manually reviewed.
Vendor-side PHI, retention, access-control, subprocessors, and model-training evidence was not found during this pass.
HealthAIdir promoted this Phase 7 seed profile from public source research. No vendor paid for placement. Buyers should verify all claims directly with Harrison-AI Medical Technologies.
Featured or sponsor placement does not affect HealthAIdir scores, verdicts, comparisons, or editorial recommendations.
Evidence: FDA list row captured with submission K253818. FDA list inclusion is an authorization signal, not an editorial endorsement. Promotion note: Phase 7 formal seed entry is based on public source anchors and remains conditional until product, pricing, privacy, security, compliance, and implementation details are rechecked. Phase 7 evidence pass 2026-06-17T00:00:00.000Z: homepage: not found product: not found privacy: not found security: not found pricing: not found compliance: not found regulatory/context: https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253818 No pricing, HIPAA, BAA, SOC 2, HITRUST, or clinical-safety claim is asserted unless an official source URL is listed above and manually reviewed. Sources: https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253818
Annalise Enterprise is included in the Phase 7 formal seed expansion as a conditional healthcare AI directory profile. The current entry is anchored on FDA AI-enabled medical device list and FDA database entry, with procurement details still requiring primary-source review.
HealthAIdir treats this page as a shortlist starting point rather than a final recommendation. Buyers should confirm product scope, deployment model, pricing, privacy terms, security controls, and compliance claims before using it in a live healthcare workflow.