Synchron to Begin Patient Enrollment for the COMMAND Trial of Brain-Computer Interface at Gates Vascular Institute
Retrieved on:
Monday, March 20, 2023
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The COMMAND trial is being conducted under the first investigational device exemption (IDE) awarded by the FDA to a company assessing a permanently implanted BCI.
Key Points:
- The COMMAND trial is being conducted under the first investigational device exemption (IDE) awarded by the FDA to a company assessing a permanently implanted BCI.
- The new site at Gates Vascular Institute marks the third approved COMMAND trial location, joining Mount Sinai Health System in New York and the University of Pittsburgh Medical Center.
- The FDA granted Breakthrough Device designation to Synchron in August 2020 and an IDE in July 2021.
- There is no guarantee of participation and principal investigators make the final determination of patient eligibility.