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 […]
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FDA sets March dates for microbiology, neurology device panel meetings
The FDA this week set two new March dates for public medical device advisory committee meetings, the first to discuss microbiology devices and the second to discuss a specific neurological device, according to official FDA releases. In the microbiology devices panel meeting, slated to be held March 8, a committee of microbiology device experts will […]