Intermediate
Breakthrough Device designation
Also known as: Breakthrough Devices Program, BDD
An FDA program giving promising devices for serious conditions faster, more interactive review. It isn't an approval.
Many BCI companies have this designation. It means more frequent feedback from the FDA and priority review, but the device still has to show it is safe and effective in trials. See the clinical trial pathway.
Last updated Sep 30, 2026. Educational content, not medical advice.