US FDA Panel Meeting Set For Alzheimer’s Device Treatment
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.
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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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