FDAFinal Rule
Medical Devices; Neurological Devices; Classification of the Electrical Tongue Nerve Stimulator To Treat Motor Deficits
HealthcareTechnology
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Summary
The FDA has officially classified a new medical device called an Electrical Tongue Nerve Stimulator that helps people recover movement after strokes or other injuries affecting motor control. This classification means the device can now be reviewed and approved for use by patients, establishing safety and effectiveness standards for this type of treatment.
Key Points
- 1The FDA is setting up rules for a tongue nerve stimulator device designed to help people regain movement and motor control after neurological injuries like strokes
- 2This classification establishes what type of medical device it is and what safety and effectiveness requirements manufacturers must meet before selling it
- 3Patients with motor deficits from conditions like stroke, spinal cord injury, or similar neurological problems could potentially benefit from this treatment option
- 4Manufacturers will need to follow FDA guidelines and submit evidence proving the device is safe and works as intended before it can be marketed to hospitals and patients
- 5This is an early step in the approval process that makes it possible for this innovative neurological treatment to move forward toward helping people
Key Dates
Published
December 19, 2025
This summary is for informational purposes only. It may not capture all nuances of the regulation. Always refer to the official text for authoritative information.
The Digest Network
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