Lifeline Biotechnologies Inc (LLBO)

[voo]

Still the trial is needed for proven evidence that the device has equal validity for detecting breastcancer...

Quote:

Section 510(k) of the Food, Drug and Cosmetic Act requires those device manufacturers who must register to notify FDA their intent to market a medical device. This is known as Premarket Notification (PMN) or 510(k). Under 510(k), before a manufacturer can market a medical device in the United States, they must demonstrate to FDA’s satisfaction that it is substantially equivalent (as safe and effective) to a device already on the market. If FDA rules the device is "substantially equivalent," the manufacturer can market the device.

That means that trials must be completed and proven effective and sensitive.

So wether FDA I or II is needed for going to the market, if Cyrcadia gets the right one, we are looking at a device which goes to the market very soon. That's where we are not holding an idea anymore but a real profit making device. And good news also for the battle against cancer!

So I say: very positive news!!!