2 ms·
When the best you can come up with are TED talks and videos on a cryptocurrency youtube channel - and the only claim to fame she has is that she co-founded a mi
by KennyBlanken 2y ago
When the best you can come up with are TED talks and videos on a cryptocurrency youtube channel - and the only claim to fame she has is that she co-founded a miserable failure of a project (One Laptop Per Child) there are serious credibility issues.
Is there any peer reviewed research?
Is the collaborating with any established, published, respected-in-their-field researchers?
After a decade of research, have they shown any actual pathway or mechanism of treatment?
They're not helped by the FDA politely saying "you haven't actually said how you intend for this thing to be used" and "your protocols don't actually specify why they are safe" and "no, we're not going to give you shit, because you haven't even done animal studies or clinial studies" and "no, you can't just say that your device has no risk of injury or death": https://github.com/OpenwaterHealth/opw_regulatory/blob/9e151dde43bbd40daee82584ea5b3a016b6c7f37/Ultrasound/FDA%20Written%20Feedback%20on%20Openwater%20LOFU%20Therapy%20System%20(Q220469).pdf https://github.com/OpenwaterHealth/opw_regulatory/blob/9e151...
She hasn't even done any animal studies, and went to the FDA seeking approval for a device...
These people are a bunch of clowns. The FDA has to explain to them that they could do thermal testing by inserting a themocouple between the device and fake skin on a testing device.