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Alzheimer's, Fujirebio 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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Medical Device Network on MSN · 2d

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

FDA clears first blood test for diagnosing Alzheimer’s

The Scientist17h

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 ...

8h

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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