Neuro Devices Panel Skeptical On Alzheimer’s Treatment
The US FDA neurological devices panel on March 21 found significant faults with Neuronix’s de novo application for its neuroAD Alzheimer’s treatment system. A key concern was that the device missed its primary endpoint in the pivotal trial.
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An Alzheimer’s treatment device from Israeli firm Neuronix Ltd has landed a date with US FDA’s Neurological Devices Panel. The committee will discuss the neuroAD Therapy System on March 21.
The templates from the US agency provide guidance to manufacturers developing antibody tests for clinical or at-home use.
Already cleared to monitor the viral load in HIV-positive individuals, the test has now been approved for initial diagnosis as well.