eClinical Technology and Industy News

Synchron’s Stentrode Brain-Computer Interface Receives Breakthrough Device Designation from FDA

Excerpt from the Press Release:

SAN FRANCISCO & NEW YORK & MELBOURNE, Australia–(BUSINESS WIRE)–Synchron, a neurovascular bioelectronics medicine company, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for Stentrode, a fully-implantable medical device that can translate brain activity or stimulate the nervous system from the inside of a blood vessel, without the need for open brain surgery. The device, which has already been implanted in patients with upper-limb paralysis, is currently being evaluated for its ability to enable patients with paralysis to regain functional independence by control of digital devices through thought alone. The Breakthrough Devices Program is designed to expedite the development and FDA review of innovative solutions for more effective treatment of irreversibly debilitating diseases or conditions, among other purposes, and will lower the burden required for Medicare reimbursement.

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