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PatD100

07/24/08 6:30 PM

#20744 RE: rossi #20743

Thanks Rossi, well folks there you have "1-3 years":
Taken together, these factors account for the 1- to 3-year delays in the introduction of new device technologies into general clinical practice within the United States as compared with Europe. Each system has strengths and weaknesses that must be evaluated within the context of different health delivery systems. Through better understanding of these systems, will we be able to recommend modifications and improvements toward improving speed and efficiency (shorter delay to US versus European testing and ultimate clinical approval), without compromising the basic demonstration of safety and efficacy that remains the US regulatory mandate.