Where we are silent, not yet certified, or evaluating a pathway.

ChironAI does not claim to be an FDA-cleared Software as a Medical Device. We do not claim that any specific clinical capability is FDA-regulated decision support. We are evaluating the SaMD regulatory pathway with counsel, and we will update this page when specific guidance is approved.

In the interim: ChironAI operates as clinical decision support under the must-review-before-final gate (see AB 489 framing on the Compliance page). The licensed clinician retains decision authority on every clinical action. Nothing on this site or in our product documentation should be read to imply otherwise.

Customers and procurement teams that require FDA clearance for their clinical AI deployment today should not select ChironAI on the assumption of clearance. Customers who recognize that AI-assisted decision support is a separate regulatory category from FDA-regulated diagnostic devices can proceed under the applicable framework for their jurisdiction.

Status today: audit-ready controls aligned to the SOC 2 Trust Services Criteria. Formal audit pathway evaluation underway with counsel and the security team. We are not currently SOC 2 certified.

We do not claim SOC 2 certification on this site, in product documentation, or in customer-facing artifacts. When the audit completes and the report is in hand, this page will update with the specific framework (Type I, Type II, or both), the report period, and the auditor identity.

Status today: ISO 27001 alignment is part of the same audit-pathway evaluation as SOC 2. We are not currently ISO 27001 certified.

Status updates will be published here as the timeline solidifies.

The auditor selection and engagement is in process. We will name the auditor on this page when the engagement is finalized, in keeping with standard SOC 2 practice.

ChironAI does not currently publish specific clinical accuracy percentages. Both editions are generally available — CDS since September 24, 2025, OM since August 12, 2026 — with institutional partnerships across the United States, Pakistan, and Ethiopia, plus a signed-agreement footprint of 13+ countries, but published peer-reviewed clinical-superiority data is not available. Platform changes are published per edition at /cds/release-notes/ and /om/release-notes/; security, access-control and PHI-handling changes are not itemised there and reach customers through their engagement.

We are deliberately conservative about clinical accuracy claims for two reasons. First, comparing AI-assisted clinical reasoning to physician-only reasoning requires controlled clinical study designs that take years and IRB approval; we are not going to fabricate or estimate percentages from non-published institutional data. Second, the architectural posture we ship under — must-review-before-final, structured workflow, audit-trailed reasoning — is designed to enhance clinician decision-making, not replace it. We position accordingly.

For the proof points we do publish (operational regions, country footprint, founding date, institutional partnerships), see the home page “By the numbers” band and the Deployments page.

ChironAI operates in the United States (primary), Pakistan, and Ethiopia, with a signed-agreement footprint of 13+ countries. For each operating jurisdiction we honor the local data-protection statute and the local clinical-AI regulatory framework that governs that jurisdiction.

For specific jurisdictional disclosures, contact our compliance team directly.

The trademarks listed in the site footer (ChironAI™, MindHYVE.ai™, Eve-Healthcare™, Eve-Fusion™, Eve-Grid™, Eve-Genesis™, HYVE™, HYVE Labs™) are trademarks of MindHYVE.ai, Inc. The Dawn Directive™ is a trademark of the California Institute of Artificial Intelligence (CIAI), used under license.

Microsoft® and Azure® are trademarks of their respective owners. Any other third-party vendor marks referenced on this site or in our subprocessor disclosures remain the property of their respective owners; references are factual and no endorsement is implied.