An FDA advisory panel has unanimously agreed that the benefits of Neuronix’s NeuroAD system, intended to slow the progress of Alzheimer’s disease, do not outweigh the risks to patient health.
Yoqneam, Israel-based Neuonix had applied for de novo clearance of the system. NeuroAD is approved for use in Europe, Australia and Israel, but the FDA panel found that clinical studies did not prove that it is effective.
NeuroAD uses focused transcranial magnetic stimulation (TMS) to stimulate target areas of the brain responsible for cognitive functions impaired by Alzheimer’s disease, according to Neuronix. This stimulation is designed to induce long-term potentiation, which the company said is associated with learning and memory processes, and makes these areas of the brain more receptive to cognitive training. Patients who receive the stimulation simultaneously receive such training.