> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Synchron ‘Breakthrough’ Status for Paralysis Brain Device
- URL: https://www.fdaweb.com/synchron-breakthrough-status-for-paralysis-brain-device/
- Published: 2020-08-28T12:00:00.000Z
- Updated: 2026-09-14T16:26:56.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5147543

FDA has granted Synchron a breakthrough device designation for Stentrode, an implantable medical device that can translate brain activity or stimulate the nervous system from inside a blood vessel without the need for open brain surgery. The device is currently being evaluated for its ability to enable patients with paralysis to regain function by control of digital devices through thought alone, the company says.

“Safety and efficacy data from a currently-active first-in-human clinical trial will be used to finalize the protocol for a pivotal FDA-enabling study that will guide evaluation for U.S. marketing approval,” the company says. Future research will evaluate Stentrode’s in patients with paralysis due to spinal cord injury, ALS, stroke and muscular dystrophy, it says.

Synchron says the device is designed to allow patients to train their brains to wirelessly control external systems without the need for using their hands or voice. It is the only investigational, implantable device, that does not require open brain surgery, it says, adding that other “neural interface devices, such as those being developed by [Elon Musk’s Neuralink](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.bloomberg.com%2Fnews%2Farticles%2F2019-07-17%2Felon-musk-s-neuralink-says-it-s-ready-to-begin-brain-surgery&esheet=52274583&newsitemid=20200827005748&lan=en-US&anchor=Elon+Musk%26%238217%3Bs+Neuralink&index=2&md5=7fbfbd7f199a30a8f2e84404f4ae27d4&ref=fdaweb.com) and [BrainGate](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fspectrum.ieee.org%2Fthe-human-os%2Fbiomedical%2Fdevices%2Fparalyzed-individuals-operate-tablet-with-brain-implant&esheet=52274583&newsitemid=20200827005748&lan=en-US&anchor=BrainGate&index=3&md5=464adff7df6bb476a135d6c964a2edca&ref=fdaweb.com), currently require drilling into the skull, and direct puncture into the brain, to achieve device implantation.”

The technology, Synchron says, relies on a “revolutionary brain-controlled handsfree app platform called brainOS to translate the brain activity into a standardized digital language, directly through thought, to control apps that restore communication and limb function. In addition, brainPort, a fully-internalized, wireless solution implanted in the chest provides high-resolution neural data transmission, and is the final component of the Synchron system.”