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

To: Peter V who wrote (5284)	6/9/1999 6:24:00 PM
From: Manfred	Respond to of 5736

U know nothing. Do some dd. I prefer letting the shorts in the dark. Manfred

To: Peter V who wrote (5284)	6/9/1999 7:00:00 PM
From: JanyBlueEyes	Read Replies (1) \| Respond to of 5736

GET YOUR FACTS HERE <<CCSI doesn't manufacture or distribute this product>> From the most recent annual report: ....In November 1998, the Company reached an agreement with a third-party manufacturer for the production of the ColorMate(Registered)TLc BiliTest(Trademark) System. The manufacturer is a medical device production contractor, is ISO 9001/EN46001 certified, and has advised the Company that it is in substantial compliance with all applicable regulatory requirements for the contract manufacture of medical devices for U.S. and European Union distribution, including requirements under the FDA's Quality System Regulation ("QSR") and the requirements applicable to the manufacture of medical devices for the European Union (including ISO 9001 and EN46001). <<the distributor must overcome a lot of inertia (heel sticks have been used for decades and are very inexpensive) to achieve significant market penetration>> CONTEMPORARY PEDIATRICS December 1998, Vol.15, No. 12 NEW PEDIATRIC PRODUCTS OF '98 No more heel sticks for bilirubin measurements As parents and pediatricians know, newborn infants frequently become jaundiced, and even a conservative management approach calls for daily monitoring of bilirubin levels in some newborns. Several years ago, the American Academy of Pediatrics (AAP) issued new guidelines for instituting phototherapy and performing exchange transfusions, resulting in fewer babies' being subjected to phototherapy. For decades, manufacturers have attempted to develop a device that can reliably measure bilirubin levels transcutaneously, which would significantly reduce the number of inconvenient and painful heel sticks. Now the FDA has approved just such a device: The new Colormate TLc-BiliTest is likely to change pediatricians' management of hyperbilirubinemia. Using a light source and optical filters, the handheld instrument measures the incremental changes of the yellow content of the skin (Figure 3). It is accurate on skin of all races, premature infants, and when used under phototherapy lights. For each set of tests, the operator places over the unit's sensor a $10 TLc-Lensette, which acts as an individual calibration and verification standard, then takes a color measurement from three different sites -- cheek, forehead, and chest of back. The device calculates the bilirubin level in mg/dl. Measurements can be downloaded to either a palmtop of laptop computer and printed for inclusion in the patient's record. The device can be battery powered or rely on an external power source, with a battery backup. For FDA approval the BiliTest was used on 2,441 newborns of various races and gestational ages. Correlation between BiliTest and serum measurements in infants undergoing phototherapy was 91%; in untreated infants the correlation was 95%. The BiliTest system, which includes the sensor, computer of palmtop, and printer, sells for about $3000, and should be widely used in hospital nurseries, pediatricians' offices, and by home care agencies. END