Invasive Brain-Computer Interfaces: Trials & Devices

Invasive brain-computer interfaces record neural signals directly from electrode arrays implanted in the cortex, achieving the highest signal resolution and decoding accuracy of any BCI approach. This topic tracks clinical trials, device engineering, and regulatory milestones across leading players including Neuralink, Blackrock Neurotech, Paradromics, and Precision Neuroscience.

11-16 · Blackrock Neurotech United States Policy & Regulation Regulatory Approval

FDA Grants Breakthrough Status to Blackrock Neurotech's MoveAgain BCI

The FDA granted Breakthrough Device designation to Blackrock Neurotech's MoveAgain BCI System on November 16, 2021. The investigational system combines an implanted array, neural decoding and wireless output with the goal of allowing people with severe paralysis to control digital and assistive devices. The designation can expedite development and review but is not market approval.

View details →

05-20 · U.S. Food and Drug Administration United States Policy & Regulation Regulatory Approval

FDA Issues Final Guidance on Implanted BCIs

The FDA issued final guidance in 2021 on implanted brain-computer interface (BCI) devices for patients with paralysis or amputation, covering nonclinical testing and clinical study design.

View details →

Invasive BCI

FDA Grants Breakthrough Status to Blackrock Neurotech's MoveAgain BCI

FDA Issues Final Guidance on Implanted BCIs