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The Scientist2d
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 ...
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 ...
Psychiatry Advisor2d
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 by the US Food and Drug Administration.
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 ...
FDA greenlights first blood test to help diagnose Alzheimer’s disease in the US
The US Food and Drug Administration has given marketing clearance to a blood test to help diagnose Alzheimer’s disease, ...
MedPage Today6d
FDA Clears First Blood Test for Alzheimer's Diagnosis
The blood test, known as the Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio, can be used to detect amyloid plaques associated with Alzheimer's in people ages 55 and older who have signs and symptoms ...
Morningstar1mon
ARUP Launches pTau 217 Blood Test To Detect Alzheimer's Disease Pathology
SALT LAKE CITY, April 21, 2025 /PRNewswire/ -- ARUP Laboratories now provides a blood test for phosphorylated tau 217 (pTau 217) to assist in identifying whether cognitive decline symptoms in ...
AFP1d
Fujirebio Receives Marketing Clearance for Lumipulse® G pTau 217/ β-Amyloid 1-42 Plasma Ratio In-vitro Diagnostic Test as an Aid to Identify Patients With Amyloid Pathology ...
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) ...
Mena FN6d
Fujirebio Receives Marketing Clearance For Lumipulse® G Ptau 217/ Β-Amyloid 1-42 Plasma Ratio In-Vitro Diagnostic Test A...
(BUSINESS WIRE )--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 ...