RE: RE: fulzy, Need for FDA clearance. Absolutely holding4now, I am a bit suprised that most people don't give GEMS the credit it deserves. This company is building an FDA aproved medicare network and GEMS is the brain at the centre of the whole thing. I am convinced that the reason the Japanesse and other big companies are interested is because of the GEMS and its ability to accurately interconnect medical devices provide for integrate over the net transmission, the plan is then to support that with a network of 24hr monitoring!. These whole system is going to be huge when they introduce other devices or biomarker monitors that they have promised. Watching from the sideline, I must say I am very impressed with the scope of this project.