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Biotech / Medical : Chromatics Color Sciences International. Inc; CCSI -- Ignore unavailable to you. Want to Upgrade?


To: Dan Packer who wrote (1456)3/18/1998 5:51:00 PM
From: wlheatmoon  Read Replies (1) | Respond to of 5736
 
Dan,

Please don't resort to this. You really think the FDA would pass muster on an inferior device? Yeah, the FDA is really a mafia run outfit out to make a quick buck. Get real. You can try to play with the numbers any way you want, but don't try to do it with such disdain for others' intelligence. Many medical studies have to exclude a large part of the population. This one is no different.

This device is used for monitoring. Get it? If it detects an abnormal level, the physician will have to decide the next step. It would be used like a pulse oximeter to measure oxygen levels in your blood. If the reading is 100% saturated, no one cares. If the reading is 92%, maybe I want a blood test to confirm it, maybe not, it just depends on the situation. If I were managing a healthy 20 year old marathoner, 92% blood oxygen saturation rate would raise a serious red flag. If I were managing a 70 smoker, I may smile because, thank god, he's at least pretty well oxygenated. Get it? Each situation will be managed differently. The bilirubinmeter will provide similar range of results that will need to be interpreted based on the situation.

I will keep answering you because I don't want the uninformed longs on this thread to get nervous by your antics. They can certainly sell, if they want, but I don't want them to be afraid.

mike

PS..Next question? What else can I clarify for you? Class is open.



To: Dan Packer who wrote (1456)3/18/1998 5:52:00 PM
From: JanyBlueEyes  Read Replies (3) | Respond to of 5736
 
<<The CCSI gizmo did better. But how much better? >>

Who cares "how much better"? The FDA gave approval. That means it works. It helps to avoid risk of infection, needless pain to the infant and less heartache for the nurses (who hate doing it) and parents, among other things.

<<Since you are really looking for thresholds, the issue was there a baby who had a toxic, or near toxic level without being captured by the color wheel or the plasma colorimeter?>>

If a baby is "near toxic level" my 10 year old could tell by how yellow the skin is.

The important issue is the device will help to "monitor" the infant so the heelstick will not have to be performed checking for jaundice. It will help the physician determine what to do if it shows increasing levels.