Summary:
INBRAIN Neuroelectronics, a health-tech company specializing in cutting-edge graphene-based neural technology, has received Breakthrough Device Designation (BDD) from the U.S. Food & Drug Administration (FDA) for its Intelligent Network Modulation System. This system is intended to be used as an adjunctive therapy for treating Parkinson’s disease.
The INBRAIN system utilizes graphene, an ultra-thin and incredibly strong two-dimensional material composed of a single layer of carbon atoms. Graphene’s exceptional electrical and mechanical properties make it an ideal choice for advancements in neurotechnology. INBRAIN’s neural platform employs machine learning software to interpret therapy-specific biomarkers, providing highly targeted and adaptive neuroelectronic therapy aimed at restoring pathological neural networks with unparalleled signal resolution.
The FDA’s Breakthrough Device Designation recognizes the potential of the INBRAIN neural platform to significantly enhance the quality of life for Parkinson’s disease patients. This designation not only acknowledges its breakthrough nature but also expedites the regulatory process, facilitating faster development and review for devices with the potential to effectively address life-threatening or debilitating conditions.
As a result of this FDA recognition, INBRAIN will benefit from ongoing feedback and a prioritized review process, paving the way for the advancement of this groundbreaking technology in clinical practice.
Article written by CataloniaBio
20/09/2023
Source:
CataloniaBio
https://www.cataloniabioht.org/news/la-plataforma-neural-intel-ligent-de-grafe-dinbrain-rep-la-breakthrough-device-designation-de-la-fda/?lang=en