Overview

• Precision Neuroscience's Layer 7 Cortical Interface has received FDA clearance, the first full regulatory approval for a wireless brain-computer interface (BCI).
• The device enables surgeons to map brain signals during procedures and allows for up to 30-day implantation in patients, expanding clinical applications.
• The Layer 7 system is designed to help paralyzed patients regain functions such as speech and movement by decoding neural signals into commands for external devices.
• Precision has temporarily implanted the device in 37 patients during surgical procedures, with the approval now allowing for longer data collection periods.
• This milestone intensifies competition in the neurotech space, where companies like Neuralink and Synchron are still in earlier stages of regulatory progress.