“…and with the cooperation of the clinical medicines. In the early 2000 s, BCI with unit recording reached the stage of clinical research ( Hochberg, et al, 2006 ), then through the 2010 s, applied research using BCI and research on improving and upgrading elemental technologies such as sensing, signal processing and decoding became popular ( Alharbi, 2023 , Kawala-Sterniuk et al, 2021 , Maiseli et al, 2023 , Saha et al, 2021 ). Around the same time, the U.S. Food and Drug Administration Center for Devices and Radiological Health (FDA-CDHR) initiated a study to prepare for an approval review of BCI based on its practical feasibility in clinical practice ( Bowsher et al, 2016 ); the FDA-CDHR issued “leap-frog” guidance in May 2021 with recommendations for the design of nonclinical and clinical testing using BCI devices for patients with paralysis or amputation ( Department of Health and Human Services et al, 2021 ), also see https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-efforts-spur-development-innovative-devices-including ).…”