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FDA Grants Breakthrough Device Designation to INBRAIN Neuroelectronics' Cutting-Edge Graphene-Powered Network Modulation Platform

INBRAIN Neuroelectronics S.L., a cutting-edge health technology company focused on developing a groundbreaking graphene-based neural platform, has recently announced a major milestone. Their Intelligent Network Modulation System has earned the highly sought-after Breakthrough Device Designation (BDD) from the U.S. Food & Drug Administration (FDA) as an adjunctive therapy for Parkinson's disease.

The core innovation behind the INBRAIN system revolves around harnessing the exceptional properties of graphene, a two-dimensional material composed of a single layer of carbon atoms. Despite its remarkable thinness, graphene possesses incredible strength, surpassing even that of steel. This remarkable blend of electrical and mechanical characteristics positions graphene as an ideal foundation for pioneering neurotechnology. INBRAIN's neural platform leverages graphene's potential to achieve unprecedented signal resolution, setting new benchmarks in the field. Powered by advanced machine learning software, the platform interprets therapy-specific biomarkers, enabling the delivery of precise and adaptive neuroelectronic therapy aimed at restoring balance in pathological neural networks.

The FDA's granting of Breakthrough Device Designation is a significant recognition of the potential of INBRAIN's neural platform to enhance the quality of life for individuals living with Parkinson's disease. This designation is reserved for devices that demonstrate groundbreaking qualities or provide compelling evidence of substantial advantages over currently approved alternatives.

Presently, deep brain stimulation is a successful therapy for Parkinson's disease within the realm of clinical brain interfaces. However, existing leads face limitations due to their relatively large size and low density, which restrict their precision when targeting smaller deep structures such as the subthalamic nucleus (STN). Additionally, their spatial and signal resolution when monitoring local brain electrical activity is constrained. The emergence of a new generation of ultrathin, graphene-based high-resolution interfaces and associated network platforms holds the potential to significantly enhance precision, efficiency, and effectiveness in deep brain stimulation, as well as closed-loop or adaptive modulation.

The Breakthrough Device Designation conferred upon INBRAIN's technology underscores its potential to potentially transform the landscape of neuromodulation for individuals dealing with Parkinson's disease and raises hope for addressing other neuropsychiatric conditions in the future.



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