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Fujirebio, Alzheimer's and FDA

FDA approves Fujirebio’s Lumipulse as first Alzheimer’s disease blood test

The US Food and Drug Administration (FDA) has approved Fujirebio Diagnostics’ Alzheimer’s disease (AD) blood test to help detect the neurodegenerative disease earlier. The decision makes the diagnostic device, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, the first AD blood test to be cleared by the regulator.

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BioWorld · 20h

Fujirebio Alzheimer’s test wins first FDA clearance

Medical Device Network on MSN · 1d

FDA grants 510(k) clearance to Fujirebio’s blood-based test for Alzheimer’s

The Scientist3h

Fujirebio Receives Marketing Clearance for Lumipulse® G pTau 217/ β-Amyloid 1-42 Plasma Ratio In-Vitro Diagnostic Test

Fujirebio today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company’s ...

9hon MSN

First Blood Test for Alzheimer’s to Be Available in US in June

The first blood test to help diagnose Alzheimer’s disease will be available from late June in the US following regulatory ...

MyChesCo on MSN3d

Fujirebio and AriBio Achieve Milestone in Biomarker Advancement for Alzheimer’s Disease

Fujirebio Holdings Inc., its subsidiary Fujirebio Diagnostics, Inc., and AriBio Co., Ltd. have announced the successful ...

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