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Alzheimer's, Fujirebio and FDA

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

The US Food and Drug Administration (FDA) has awarded 510(k) clearance to Fujirebio’s Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio in vitro diagnostic (IVD) test for evaluating amyloid pathology in individuals under assessment for Alzheimer's disease and other cognitive decline causes.

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Medical Device Network on MSN · 2d

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

FDA clears first blood test for diagnosing Alzheimer’s

The Scientist21h

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 ...

11h

FDA approves first blood test to detect Alzheimer’s, marking major breakthrough

Experts say the test could dramatically improve access to earlier, more accurate diagnoses, particularly for older Americans ...

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