A company that manufactures an implantable has received the green light from the Food and Drug Administration to conduct a clinical trial in human patients. Synchronization plans to begin an early feasibility study of his Stentrode implant later this year at Mount Sinai Hospital, New York with six subjects. The company said it would assess “the safety and effectiveness of the device in patients with severe paralysis.”
Synchron received FDA green light ahead of competitors like Elon Musk’s . Before these companies can sell BCIs commercially in the United States, they must prove that the devices work and are safe. FDA to provide guidance for BCI device trials for patients with paralysis or amputation during a webinar Thursday.
Another clinical trial of Stentrode is underway in Australia. Four patients received the implant, which is used “for data transfer from the motor cortex to control digital devices,” Synchron said. According to data published in the Journal of NeuroInterventional Surgery, two of the patients were able to control their computers with their thoughts. They performed work-related tasks, sent text messages and emails, and performed online banking and shopping.
According to Synchron, it takes approximately two hours to implant a Stentrode device with a minimally invasive procedure. The device is implanted through a blood vessel at the bottom of the neck and maneuvered into the brain. Synchron CEO Thomas Oxley said the device could be available for purchase within three to five years.
All products recommended by Engadget are selected by our editorial team, independent of our parent company. Some of our stories include affiliate links. If you buy something through any of these links, we may earn an affiliate commission.