"Breakthrough" devices have to be devices which show a significant improvement to quality of life over existing treatments for "life threatening or irreversably debilitating" conditions, using breakthrough technology in a space where an existing device doesn't exist yet.
So it's less "we made a better pacemaker that uses ChatGPT" and more "this new ventilator can keep people alive even when their lungs are filling with fluid and they're going to die otherwise".
Really what happens is your application is given a higher priority level and dedicated reviewers. They're still going through the full review process, its just they're focusing on your submission.
Why? I do this sort of technique all the time at work to keep things moving. “I’m gonna ship this code on Friday and if I don’t hear anything before then I’ll assume no news is good news and do it!”.
There should always be an upper bound to how long somebody can block your progress. If something was so important that they want to block me, why didn’t they tell me before Friday? That was ample time to raise objections.
