News

"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 ...
BusinessMirror9h
FDA clears breakthrough blood test for Alzheimer’s disease diagnosis
Fujirebio recently announced that the US Food and Drug Administration (FDA) has granted clearance for the company’s Lumipulse in-vitro diagnostic (IVD) test for the assessment of amyloid pathology in ...
Medical Device Network on MSN4d
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 ...
PMLive3d
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 ...
The Scientist3d
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 ...
STAT7d
FDA clears first blood test for diagnosing Alzheimer’s
The FDA has approved the first blood test for diagnosing Alzheimer’s disease, which could speed the path to treatment for ...
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 ...
BioWorld4d
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 ...
First blood test for Alzheimer's gets FDA greenlight: 3 things to know
The FDA has cleared the first blood test to diagnose Alzheimer's which works by measuring the amount of pTau 217 and ...
FDA approves blood test to detect Alzheimer’s disease
The test has a complicated name: The Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio. But the goal of the test, created by ...
FDA Clears First Blood Test to Diagnose Alzheimer’s Disease
The FDA greenlit marketing for the first blood test to help diagnose Alzheimer’s disease. Experts believe this will increase ...
Fierce Biotech7d
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 ...