Synchron receives green light from FDA to begin breakthrough trial of implantable brain computer interface in US

Synchron, a venture-backed brain data transfer company, announced last week that the U.S. Food and Drug Administration (FDA) has approved its Investigational Device Exemption (IDE) application for its flagship product, the Stentrode™ motor neuroprosthesis designed to use brain data to control digital devices and achieve improvements in functional independence. This early feasibility study (EFS) of the device will begin later this year at Mount Sinai Hospital in New York, and will assess the safety and efficacy in patients with severe paralysis. The system is designed to facilitate better communication and functional independence for patients by enabling daily tasks like texting, emailing, online commerce and accessing telemedicine.

Four patients in Australia have received the Stentrode implant and are utilizing this neuroprosthesis for data transfer from motor cortex to control digital devices. Data from the first two patients in this study demonstrated each patient was able to control their devices to text and type through direct thought. Following implantation and a short period of machine learning-assisted training, they were able to use the system unsupervised in their homes to send text messages, do online shopping and manage their finances.

The Stentrode device is delivered into the brain via the blood vessels in a minimally invasive 2-hour procedure, similar to the insertion of stents in the heart. No robotic assistance is required for the procedure, which can be performed in widely available angiography suites. The implant is fully internalized with no wires coming out of the head or body.