TheStockman,
where I come from (the Caribbean)we have all kinds of skin tones, and nobody have ever turn ashy or bleached. Just darker (or red).
Phototherapy heat radiation is minimal under NICU circumstances, the light panels have a fan to keep then cool at all time, the distance of the lights to the baby is also control (18 inches), and babies are in Isolettes to further regulate temperature and humidity (to decrease skin evaporation). Changes in skin color are not frequently drastic, but subtle.
Please, provide the link or reference to Dr Maisels bleaching statement, I would like to know what does he mean about it. Anyway sprx will figured out how to deal with the "bleaching" whatever that is.
I did not mentioned the thousand plus kids in the Elmhurst study? my point and very clear: CCSI did test only 61 kids on phototherapy. The pre-phototherapy ones are irrelevant, sprx bilicheck is already approved for that group. (anyway I provided the link to the abstract).
Nicus and newborn nurseries are the almost only market for this devices (Colormate and Bilicheck). Babies in the first 1 week of life are the probable patients, minimal if any use in other populations.
One could make the case for a pediatrics ER, clinic or practice group to have it if the device cost were $50, but the cost is $3,000. To charge for the cost of each test is cumbersome at best (try to get an HMO to pay).
If Nicus are not a priority for Sprx then call the CEO again, his strategy is worth zero.
Before, in this board, many claimed that Sprx will be FDA approved in years if at all. Well, they are out in the market, and with the Respironics big salesforce power most probably Sprx will get in Nicus faster than CCSI.
Now the claim is it will take years to get the "phototherapy" label.
I would not count on that.
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