Neuralink gets FDA's breakthrough device tag for 'Blindsight' implant

reuters.com

The FDA's breakthrough tag is given to certain medical devices that provide treatment or diagnosis of life-threatening conditions.

Blindness is extremely debilitating, but it's not generally a life-threatening condition.

I'm glad that they're going forward with it. I'm just curious whether TFA is mis-stating what's going on, or if the FDA is bending its own rules.