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BioWorld - Saturday, March 14, 2026
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Home » FDA grants breakthrough designation to Synchron’s Stentrode brain-computer interface
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FDA grants breakthrough designation to Synchron’s Stentrode brain-computer interface

Aug. 28, 2020
By Liz Hollis
Neurovascular bioelectronics medicine company Synchron Inc. has received good news in the form of a breakthrough device designation for its Stentrode. The U.S. FDA granted the designation for the fully implantable medical device that can translate brain activity or stimulate the nervous system from inside a blood vessel. As a bonus for patients, the device does not require open brain surgery. “As this is a first-of-its-kind device, we look forward to working closely with the FDA to prioritize development of the Stentrode and ensure access for patients with paralysis, as well as lay the groundwork for future indications for brain-computer interfaces,” said Thomas Oxley, CEO of Synchron.
Medical technology Regulatory Neurology/psychiatric FDA

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