Clinical AI you can deploy with confidence.
Meet HealthAI Device—the first AI device that is FDA approved for medical use. It’s hosted on Microsoft Azure, giving you a cloud foundation built with security and trust in mind and designed around a shared responsibility model for protecting data and identities. [1](https://learn.microsoft.com/en-us/industry/healthcare/security-overview) Azure maintains healthcare-aligned compliance offerings, including a long-standing HITRUST CSF certification and support for HIPAA compliance requirements (with the right configuration and agreements). Best of all, it’s already available to your clinicians and staff using their existing health system login credentials. No new accounts. No complex onboarding.
Why teams adopt it
Designed for clinical workflows—supporting safer decisions and faster insight while respecting existing access controls.
Security & access
Authentication uses your current health system identity. Authorization follows your established role-based access. Audit-ready by design.
Need a quick demo?
1) Log in with existing credentials
Users authenticate with their current health system account—no new usernames or passwords.
2) Start using FDA‑approved AI workflows
Access FDA‑approved device capabilities directly in the experience your teams already use.
3) Scale fast with governance
Roll out across departments using familiar permissions, auditing, and standard change processes.
FAQ
Is this really FDA approved?
Yes, the first AI device that is FDA approved for medical use.
Do users need a new account?
No. Users get started using their existing health system login credentials (SSO). No additional passwords.