News

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 ...
Alzheimer's diagnosis with blood test becomes reality: All you need to know
The USFDA has approved the first-ever blood test to help diagnose Alzheimer's disease, offering a faster, less invasive, and ...
Best Life on MSN1d
FDA Approves First-Ever Alzheimer's Blood Test—Here's Who Will Benefit
However, that could all change thanks to a new blood test called Lumipulse. On May 16, the U.S. Food & Drug Administration ...
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 ...
PMLive1d
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 ...
Psychiatry Advisor11h
FDA Gives Marketing Nod to Blood Test for Diagnosing Alzheimer Disease
The first in vitro diagnostic device that uses blood samples to detect Alzheimer disease has been granted marketing clearance ...
New Atlas1d
Breakthrough Alzheimer's blood test has been approved for the US
The very first blood test for Alzheimer's disease detection has been green-lit by the US Food and Drug Administration (FDA), ...
BioWorld1d
Fujirebio Alzheimer’s test wins first FDA clearance
Fujirebio Diagnostics Inc.’s Alzheimer’s disease assay received the U.S. FDA’s first clearance for a blood test for the ...
BioSpace2d
FDA Clears First Alzheimer’s Blood Test, Lending ‘Momentum’ to Lilly’s Kisunla, Biogen’s Leqembi
Analysts at BMO Capital Markets said in a weekend note that a non-invasive blood test could help boost uptake of Alzheimer’s ...
Everyday Health on MSN18h
First Blood Test to Diagnose Alzheimer’s Cleared by FDA
The Lumipulse blood test identifies the presence of amyloid plaques, a hallmark of Alzheimer’s disease that impairs normal ...
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 ...
Fierce Biotech4d
FDA clears its first blood test for diagnosing Alzheimer's disease, with Fujirebio's Lumipulse
The FDA said it has issued its first official green light for a blood test to help diagnose Alzheimer’s disease, adding that ...