What porkie have I told? What I've said is basically:1) Lumos...

What porkie have I told? What I've said is basically:

1) Lumos did not receive a FDA approval, it received an FDA clearance

2) FDA clearances are less rigorous than FDA approvals and are easier to obtain

Your extract backs what I'm saying: that approval and clearance are two separate processes.

I'd strongly recommend all holders to do their own research on the differences between FDA approval and FDA clearance. Don't just listen to the cheerleaders here making LDX's FDA clearance out to be a huge tick of approval of some sort - it's not. The FDA will grant FDA clearance to devices without testing its safety or effectiveness, ie. it will give clearance to devices whether it works or not. It is not a difficult standard to pass.