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Alzheimer's, FDA and AD blood test

"Important" Alzheimer's treatment breakthrough gets FDA approval

Michelle Tarver, of the FDA's Center for Devices and Radiological Health, said: "Today's clearance is an important step for Alzheimer's diagnosis, making i

PMLive · 1d

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

STAT · 4d

FDA clears first blood test for diagnosing Alzheimer’s

· 15h

First Alzheimer’s Blood Test Available in US in June

The lack of quick and easy tests has until now slowed the rollout of new Alzheimer’s drugs like Eisai Co. and Biogen Inc.’s Leqembi and Eli Lilly & Co.’s Kisunla.

AARP · 1d

What to Know About the First FDA-Cleared Blood Test for Alzheimer’s Disease

Becker's Hospital Review · 1d

Blood test for Alzheimer’s gets FDA green light

The Scientist1d

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 Lumipulse® G pTau 217/β-Amyloid 1-42 Plasma Ratio in-vitro diagnostic (IVD) test for the assessment of amyloid pathology in patients being evaluated for Alzheimer’s disease and other causes of cognitive decline.

Medical Device Network on MSN2d

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.