News

Non-invasive Neurostimulation Device Wins FDA’s Breakthrough Status

Cognito Therapeutic’s neurostimulation device — a next-generation digital therapeutic designed to treat memory and cognition symptoms in Alzheimer’s disease — has been granted a breakthrough device designation by the U.S. Food and Drug Administration (FDA). The device, part of a new class of disease-modifying digital therapies, uses proprietary,…

New Technique May Enable Early Diagnosis of Alzheimer’s

A newly developed technique could make it easier to measure very small concentrations of molecules, which may have implications in early diagnostic testing for Alzheimer’s and other diseases. The technique was described in Research, in the study “Single-Atom Nanozymes Linked Immunosorbent Assay for Sensitive Detection of…

Support for Research, Patient Care in US 2021 Budget Wins Praise

The Alzheimer’s Association and its advocacy affiliate, the Alzheimer’s Impact Movement (AIM), are lauding recent actions by lawmakers that will fund and advance multiple Alzheimer’s disease policies. The advancements are part of the $1.4 trillion government funding bill for the 2021 fiscal year that was passed by Congress on Dec. 21 and…

Fujirebio Seeks FDA’s Premarket Approval for Diagnostic Test

Fujirebio Diagnostics has submitted a premarket notification — also known as a 510(k) — to the U.S. Food and Drug Administration (FDA) for its Alzheimer’s diagnostic test, called Lumipulse G β-Amyloid Ratio (1-42/1-40). If cleared by the FDA, it will be among the first commercially available lab tests to…