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Nia Therapeutics Wins First FDA Breakthrough Designation for a Brain Implant That Treats Memory Loss After Traumatic Brain Injury

The FDA granted Breakthrough Device Designation to Nia Therapeutics' 60-channel Smart Neurostimulation System, a closed-loop brain implant that uses machine learning to detect impaired memory encoding and deliver targeted stimulation, marking the first such designation for TBI-related memory loss.

4 min read3 sources