Blackrock Neurotech high-density array receives FDA Breakthrough designation

The Breakthrough Device designation is expected to accelerate FDA review of the next-generation recording array intended for multiple indications.

强脑科技消费级脑控产品获批上市

BrainCo receives approval for consumer neurofeedback product

The product targets attention training and rehabilitation support, among the first domestically approved consumer-grade BCI products.

Onward Medical ARC-EX system receives CE mark

ARC-EX is a non-invasive spinal cord stimulation device aimed at restoring hand function in spinal cord injury patients, now cleared for EU commercial sale.

FDA clears Precision Neuroscience Layer 7 array for 30-day implantation

The device was previously cleared only for intraoperative use up to 30 minutes. Extending to 30 days opens the door to longer-duration clinical studies.