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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 ...
"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 ...
88.5 WFDD1h
First FDA-cleared Alzheimer's blood test could make diagnoses faster, more accurate
The first Alzheimer's blood test cleared by the Food And Drug Administration is poised to change the way doctors diagnose and ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
FDA greenlights marketing of first Alzheimer's blood test for some patients
Japan-based Fujirebio's test, which helps doctors diagnose Alzheimer's disease, is intended for patients with signs of ...
STAT4d
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 clears 1st blood test to help diagnose Alzheimer's disease
The test is for those aged 55 and older who are already exhibiting signs and symptoms of the disease, the FDA says.