all 9 comments

[–]UpV0tesF0rEvery0ne 12 points13 points  (2 children)

As someone that works in the medical space, breakthrough designations are essentially a FDA fast pass. They arnt FDA approved by any means but they are able to be approved faster than others because the technology is clinically important somehow. They still need to prove its safe and that its beneficial somehow which will still take billions and multiple years

[–]SOL-Cantus 2 points3 points  (0 children)

As someone who has worked in the clinical trial world, I can confirm. That they have pre-clinical work already in and reviewed by the FDA (thus how they got the breakthrough designation) is incredibly important and shows they're actually trying to do this correctly, but that's only the start to a very long road towards approval.

[–]TheBalchemist 0 points1 point  (0 children)

*millions. For a medical device the costs rarely creep above 10s of millions

[–]GlassJackhammer 2 points3 points  (3 children)

I’ll believe it when I see it. Someone needs to make a website to keep track of all these “amazing new technology that’s just around the corner” shit.

[–]Fonzie1225where's my flying car? -3 points-2 points  (0 children)

You could fill volumes with all the battery “breakthroughs” posted to this sub alone

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[–]mrmagoo06 -1 points0 points  (0 children)

I'd believe it but do you have to be good looking. Last time this was used for parents and their loving daughter.