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Biotech / Medical : Chromatics Color Sciences International. Inc; CCSI
CCSI 28.71-2.4%Nov 4 3:59 PM EST
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To: JanyBlueEyes who wrote (4966)3/19/1999 1:41:00 AM
From: THESTOCKMAN  Read Replies (1) of 5736
 
Well, it took CCSI 9 years just to develop the algorithm. Any evidence collected in Europe will be invalid in the U.S. as skin types are different in European babies. There have to be correlations done on all different skin types with results coming in after the phototherapy is initiated. This is a long drawn out process because many babies' skins react differently to the ultraviolet light from bleaching to reddening to tanning, etc. These have to all be calibrated for and included in the program.

At least three separate sites in the U.S. would have to be done with several hundreds of babies tested at each site. This could take a year or two. Then, IF their algorithm was correct(assuming they have one) and the correlations were good, the new 510K submission could be started and might take a year or two past that for approval. It's obvious that people just don't understand how difficult the process of adjusting the skewed results after phototherapy affects the skin.

If you're worried that SPRX will get into any NICUs in the U.S. for several years, don't be. It's just not possible. They themselves have even stated that that is not their primary market (mainly because of their non-ability for use under phototherapy).
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