The iMOST platform is not yet cleared or waived by the FDA. U.S. FDA 510(k) and CLIA waiver submissions are currently in preparation.

Yes. Under current CE-mark approvals, POCT is explicitly included in the intended use. This supports deployment in decentralized and near-patient settings.

iMOST is currently obtaining PST-specific approvals in select regions. For CE-marked regions, the platform is currently positioned for POCT (professional use) rather than PST. However, preparation for future PST support is underway. Always refer to local labeling/IFU for defined users and settings.

• The iMOST platform (specifically iMOST-L and iMOST-U) carries CE-IVD / IVDR marking. It is registered or deployed across multiple regions, including the EU and parts of Asia. Manufacturing occurs in ISO 13485–certified facilities that have been audited by global IVD partners.