The US Food and Drug Administration (FDA) has awarded 510(k) clearance to Fujirebio’s Lumipulse G pTau 217/β-Amyloid 1-42 ...

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

Japan-based Fujirebio's test, which helps doctors diagnose Alzheimer's disease, is intended for patients with signs of ...

The US Food and Drug Administration (FDA) has approved Fujirebio Diagnostics’ Alzheimer’s disease (AD) blood test to help ...

The FDA has approved the first blood test for diagnosing Alzheimer’s disease, which could speed the path to treatment for ...

The FDA said it has issued its first official green light for a blood test to help diagnose Alzheimer’s disease, adding that ...

Fujirebio Diagnostics Inc.’s Alzheimer’s disease assay received the U.S. FDA’s first clearance for a blood test for the ...

The test is for those aged 55 and older who are already exhibiting signs and symptoms of the disease, the FDA says.

The Food and Drug Administration (FDA) announced Friday it had cleared a new test to help diagnose adults with Alzheimer’s ...

The US Food and Drug Administration has given marketing clearance to a blood test to help diagnose Alzheimer’s disease, ...

Not all people should take Fujirebio's new test. The FDA says that it is "intended for patients presenting at a specialized care setting with signs and symptoms of cognitive decline" and is ...