CE may be quicker than FDA, but the criteria for approval here in Europe are almost the same! VALID results must be obtained. In trials positive result in new medicine or applications can only be seen valid if the population is large enough, otherwise the chance of coincidence (p) is to large. Normally we hold p<0,05. My concern in all this is the number of tested patients..... Hopefully it is enough and the outcome of the clearance is not to be testing more patients..... But even then I'll wait. This device is to be huge!!!