RE: Clinical Trials24 Jul 2020 16:20
TopCatz I'm hoping that they clear this up but in my humble opinion we may dealing with two issues here.
The FDA want 15 units to test which is fair enough such a test for a medical device should take no longer than 6 months. They need to ensure the device does what it says, provide high levels of oxygen ect.
The other trial was a test for self use, can people follow instructions safely and use the device.
If they can use it, it's considered a pass and this information would be given to the FDA.
So the FDA need to approve the device, does it work, is it reliable, then they would consider passing it for self use where there is a huge market worth millions.
IMHO there are two tests here, and according to the clinical trial website one of them has concluded. I'm no expert on this and clarity from TEK would be appreciated otherwise we'll all just lose faith in them.