Yes. The iMOST platform is CE-marked, and POCT is included in the intended use under current approvals. This supports use in decentralized and near-patient settings, subject to local regulatory acceptance.
- Q
Does iMOST include POCT in its intended use?
A - Q
What regulatory approvals does iMOST currently have?
A- CE-IVD / IVDR (iMOST-L and iMOST-U)
- Registrations or deployments in multiple regions (e.g., EU, parts of Asia)
- ISO 13485–certified manufacturing, including audits by Roche Diagnostics