Digital Health Briefings

Synchron: only company to have FDA approval to conduct clinical trials of a permanently implanted brain-computer interface

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Synchron is the only company to have FDA approval to conduct clinical trials of a permanently implanted BCI – a device aiming to convert people’s thoughts with paralysis – into actions. Synchron has developed an endovascular brain-computer interface that can access every corner of the brain using the blood vessels. The platform launches neuro interventional electrophysiology, transforming three medical pillars: neuroprosthetics, neuromodulation and neurodiagnostic. 

In July 2022, Synchron conducted the first clinical trial of a brain implant that returns the power of communication to severely paralyzed people. Synchron’s Stentrode system was implanted in the trial’s first participant at Mount Sinai West hospital in New York City. Synchron’s BCI technology doesn’t require open-brain surgery or any drilling into the skull. Instead, it can be put in place in a minimally invasive surgery that takes only about two hours. 

Synchron’s BrainOS technology platform collects those signals from a receiver unit implanted in the user’s chest. It translates them in real-time into clicks and keystrokes on a computer or mobile device. An additional eye-tracking device is used to control the movements of the computer cursor. The intended result is a system that allows people with severe paralysis to send texts and emails, access online banking and shopping services, complete telehealth visits and more – using only their thoughts to control the tech. 

Billions of inaccessible neurons and over 400 miles of blood vessels navigate every part of the brain. Brain.io is a motor neuroprosthesis – designed to bypass damaged neural pathways in patients with severe paralysis, allowing them to restore motor capabilities, including control of digital devices. Each device replaces an intact motor neuron’s essential function to record, transmit, translate, and act on brain signals. The node consists of the stentrode and our internal receiver-transmitter unit placed in the chest under the skin. It records brain signals from the motor cortex and transmits raw wireless data to external devices. 

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