INBRAIN Neuroelectronics Earns Prestigious FDA Breakthrough Device Designation for Groundbreaking Graphene-Enhanced Intelligent Network Modulation Platform

Wednesday, September 20, 2023

INBRAIN Neuroelectronics, a cutting-edge health-tech company dedicated to pioneering neurotechnology, proudly announces that its revolutionary Intelligent Network Modulation System has received Breakthrough Device Designation (BDD) from the U.S. Food & Drug Administration (FDA) for use as an adjunctive therapy in the treatment of Parkinson's disease. The INBRAIN system harnesses the extraordinary properties of graphene, a two-dimensional material composed of a single layer of carbon atoms. Graphene's unique combination of electrical and mechanical attributes makes it an ideal candidate for innovations in neurotechnology.

INBRAIN's neural platform technology achieves an unparalleled level of signal resolution, thanks to advanced machine learning software that deciphers biomarkers specific to therapy. This technology allows for the delivery of precise and adaptive neuroelectronic therapy, facilitating the restoration of disrupted neural networks. The FDA's designation of the INBRAIN neural platform as a Breakthrough Device underscores its potential to significantly enhance the lives of individuals dealing with Parkinson's disease. The BDD designation is reserved for devices that represent a breakthrough or demonstrate a substantial advantage over existing approved alternatives. It also streamlines the development and FDA review process for devices addressing life-threatening or debilitating conditions.

INBRAIN's next-generation ultrathin graphene-based high-resolution interfaces and the accompanying network platform hold the promise of greatly improving the accuracy, efficiency, and effectiveness of Deep Brain Stimulation (DBS) and closed-loop or adaptive modulation. The FDA's recognition of the INBRAIN system as a Breakthrough Device signifies the potential for a paradigm shift in the field of neuromodulation, not only for Parkinson's disease but also for other neuropsychiatric conditions in the future.

The FDA's acknowledgment of the INBRAIN system as a Breakthrough Device means that the company will benefit from ongoing feedback during the regulatory process and an expedited review by the agency. This marks a significant step forward in the effort to bring this innovative technology to patients in need.

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