Graphene-based neural platform earns breakthrough device status

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…

FDA Grants Breakthrough Device Designation for nQ Medical’s neuroQWERTY

The U.S. Food and Drug Administration (FDA) has granted breakthrough device designation to nQ Medical’s neuroQUERTY software, which is designed to monitor brain health and Parkinson’s disease progression. Breakthrough device status is given to medical devices that have the potential to be an effective treatment or…

FDA Grants Breakthrough Device Designation to Amprion’s PMCA Early Detection Tool

The U.S Food and Drug Administration (FDA) has granted a Breakthrough Device designation to Amprion’s proprietary technology, Protein Misfolding Cyclic Amplification (PMCA) — a device that holds the potential to diagnose Parkinson’s disease at a much earlier stage than current diagnostic methods. If approved by the…