"The U.S. Food and Drug Administration (FDA) has granted breakthrough device designation to Inbrain Neuroelectronics’ neural platform for its potential to provide more effective deep brain stimulation (DBS) as an add-on Parkinson’s treatment."
"The platform — called Intelligent Network Modulation System — combines skin-like graphene material and artificial intelligence (AI)-powered data analysis to understand and control the brain’s neural networks to better ease Parkinson’s symptoms."
"The designation, which recognizes medical devices that represent a breakthrough or offer improvements over existing ones for life-threatening or irreversibly debilitating diseases, sprints Inbrain’s platform into a fast lane through the FDA’s regulatory review process. Other advantages include frequent interaction with the agency."