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The BCI category that motor and speech restoration overshadowed: Nia Therapeutics has FDA Breakthrough Designation for a preclinical brain implant for TBI-related memory loss
Nia Therapeutics, an Allston Massachusetts company co-founded in 2018 by University of Pennsylvania memory neuroscientist Michael Kahana and cognitive neuromodulation researcher Daniel Rizzuto, received FDA Breakthrough Device Designation on 13 March 2026 for its Smart Neurostimulation System (SNS), indicated for episodic memory loss in adults with prior moderate-to-severe traumatic brain injury. The SNS is a 60-channel wireless closed-loop cortical implant whose platform hardware was validated in a sheep study published in Brain Stimulation in December 2025. It is preclinical: no human implant yet, IDE application planned for 2026.