Key Features

• According to the vendor's product page, Comprehensive Care identifies 13 findings across chest X-ray and non-contrast head CT in under 90 seconds, integrating into existing PACS/RIS as a resizable, no-click overlay window.
• The vendor states thresholds are individually configurable per finding (up to five operating points each) to let a site tune sensitivity/specificity to its own clinical population.
• The vendor states the underlying models were trained on more than 1 million studies with over 500 million hand-annotations from more than 145 expert radiologists.
• The U.S. product portfolio has accumulated numerous individual FDA 510(k) clearances (chest X-ray findings including pneumothorax/tension pneumothorax differentiation, pleural effusion, pneumoperitoneum, and vertebral compression fracture; head CT findings including multiple intracranial hemorrhage subtypes, obstructive hydrocephalus, and acute infarct).
• The vendor's obstructive hydrocephalus finding is stated to be eligible for a separate Medicare New Technology Add-on Payment (NTAP) of up to $241.39 per patient; this specific reimbursement-eligibility claim is vendor-stated.

Compliance & Security

• HIPAA Compliance: Yes
• FDA Status: Cleared (510(k)), on a per-finding basis. The vendor's product page states the current U.S. portfolio totals 13 FDA-cleared findings (8 on non-contrast head CT, 5 on chest X-ray); consistent with an actively growing, incrementally cleared portfolio rather than a single static clearance - buyers should confirm which specific findings are currently cleared and available at the time of purchase, since this number has changed repeatedly.
• Security certifications: Harrison.ai holds GDPR compliance, AICPA SOC (badge links to the AICPA SOC-for-Service-Organizations program), ISO 27001, and a Spanish ENS ("Esquema Nacional de Seguridad") certification at the "Alta" (high) level.

Integration & Workflow

• The platform integrates directly with a site's existing PACS and RIS via a no-click overlay window.
• Platform: Deployed within existing radiology PACS/RIS workflow (not a standalone app); no separate EHR-specific integration was described.

Pricing & Access

• Not publicly listed; the vendor's site directs prospective customers to "Book a demo" rather than publishing pricing.
• No free trial is advertised on the vendor's public site.

Doxiverse Assessment: Strengths & Limitations

• Strengths: Harrison.ai/annalise.ai has one of the more extensively, independently documented FDA clearance histories in this space, with more than a dozen individual 510(k) clearances. It offers broad single-platform coverage (13 findings across two modalities) rather than requiring multiple point solutions, and states large-scale international deployment.
• Limitations/Risks: The FDA-cleared finding count has changed multiple times across the sources reviewed (9, 10, then 13), so buyers should verify the currently cleared finding list directly with the vendor or the FDA's public database at time of purchase rather than relying on any single figure. As with any AI triage/notification (CADt) tool, the product is explicitly positioned as assisting worklist prioritization rather than as a diagnostic device, buyers should confirm the specific FDA "intended use" language for each finding before deployment, since triage/notification clearance is a narrower regulatory category than a diagnostic clearance.

Ideal User Profile

• Best for: Radiology departments, emergency/acute care imaging services, and teleradiology providers handling high volumes of chest X-ray and non-contrast head CT studies who want a single platform covering multiple time-sensitive and incidental findings rather than several separate point solutions, based on the vendor's stated large-scale hospital/health-system and NHS deployments.
• Not ideal for: Sites needing AI coverage for imaging modalities or body regions outside chest X-ray and non-contrast head CT.

Disclaimer - This profile was compiled from publicly available sources including the vendor's own website, regulatory filings, press coverage, and independent research. Vendor claims are labeled as such and have not been independently audited by Doxiverse. Product features, pricing, certifications, and regulatory status change frequently and may no longer be current; verify all details directly with the vendor before making a purchasing decision. The "Doxiverse Assessment" and "Ideal User Profile" sections reflect Doxiverse's independent editorial analysis based on available sources at the time of writing, not the vendor's endorsement, and the vendor may disagree with this characterization. This profile is provided for informational purposes only and does not constitute a recommendation, endorsement, or professional/legal/clinical advice. Report inaccuracies to contact@doxiverse.com