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RegulationSeptember 2, 2026

Health Canada issues licences to Fujirebio’s Lumipulse assays

Fujirebio received Class II Medical Device Licences from Health Canada for its Lumipulse G NfL Blood and Lumipulse G pTau 217 Plasma assays. These blood-based biomarker tests are used in neurodegenerative disease diagnostics. The clearances expand regulatory authorization for the assays beyond prior markets.

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