3 ms·
Sounds really interesting, best of luck! You mentioned trials, are you trying to get FDA approved?
by samename 5y ago
Sounds really interesting, best of luck!
You mentioned trials, are you trying to get FDA approved?
- pedalpete 5y agoWe're just looking at FDA atm. We don't have to get approval, but we're looking at registering as a medical device (Class 1, maybe Class 2). Do you have any experience with that process? We're implementing existing research, with a bit of our own spin on it. My co-founder and I both come from CSIRO (Australia's Science and Technology Org), so our trial is a combination of measuring that we've implemented the science correctly, it's having the impact we want/expect, and we can prove it. This isn't a medical trial, but we are following regular research protocols.