Emerging technology: Implanted brain computer interface devices for patients with paralysis or amputationApril 2, 2019 Download PDF
An Implanted Brain Computer Interface (BCI) device may sound like something out of science fiction, but FDA apparently believes these devices are on their way to becoming a reality. FDA recently released a draft guidance document that provides recommendations on how to gain approval to conduct clinical studies of these devices in support of eventual marketing clearance.
- Adrienne R. Lenz
Principal Device Regulatory Expert