Implant Type
intracortical
Electrodes
96
Channels
96
FDA Status
510k-cleared
Clinical Stage
Multiple FDA-approved IDEs; 510(k) cleared for <30 day monitoring; 30,000+ aggregate patient-days
Status
investigational
About
The Utah Intracortical Electrode Array is the gold-standard research BCI platform, in continuous human use since 2004. The array consists of 96 silicon needles in a 10x10 grid (minus 4 corners) on a 4mm x 4mm substrate, each 1.0-1.5mm long with iridium oxide or platinum tips. Multiple arrays can be combined for up to 1,024 electrodes (400-600 typical). Documented recording longevity exceeds 8 years in a single patient. Over 30 research participants have used the system across multiple IDE studies with zero reported serious adverse device events across 30,000+ aggregate days.
Target Conditions
ALSspinal cord injurylocked-in syndromestrokecortical mapping
Milestones
2004-01First human implant by BrainGate consortium (Matthew Nagle)
2012-05Cathy Hutchinson controls robotic arm for self-feeding (Nature)
2016-01Ian Burkhart restores voluntary hand movement via Utah Array + FES
2020-01Blackrock Microsystems rebrands as Blackrock Neurotech
2021-01FDA Breakthrough Device Designation for NeuroPort Array
2024-01Tether invests $200M, acquires majority stake
FDA Regulatory Pathway
No FDA Regulatory Status
This device does not have a current FDA designation. It may be a research tool, preclinical device, or consumer product not subject to FDA medical device regulation.
FDA Device Regulatory Guidance ↗