To: HedyVP who wrote (4581 ) 9/10/1998 9:57:00 AM From: JanyBlueEyes Read Replies (2) | Respond to
CCSI INFORMATION PAGE - JAUNDICE & BILIRUBIN REFERENCES, COLORMATE TLc-BiliTest(TM) SYSTEM PRODUCTS, FDA 510K, CONSOLIDATED NEWS RELATED TO BILIRUBIN ASPECT WHAT IS JAUNDICE? -AND- FREQUENCY OF TESTING NEWBORNS Message 4436306 - Lots of information hereCOLORMATE TLc-BiliTest(TM) SYSTEM PRODUCTS Message 4329124 RECENT DEVELOPMENTS Message 5703900 - 9/98 - Article in Pediatrics on a major study done using Chromatics' TLc-BiliTest . "The study involved infants receiving routine care in two large inpatient facilities and was designed to determine whether the device could provide clinically useful information on the concentration of serum bilirubin in a diverse group of hospitalized newborns. These infants were to include both full-term and premature infants of multiple races, as well as infants receiving phototherapy ......"Message 4931593 - 6/22/98 - Physician's Weekly - NEW ORLEANS-For newborn jaundice in an era of fast discharge, the eyes don't have it. "In a study of 615 Hispanic, 110 Caucasian, 103 Asian, and 72 African American infants, a team at Mount Sinai in New York found that a color-filtered light meter equals heelstick blood tests, with no lab delay....."APPROVAL FROM FDA techstocks.com - Actual 510K Summary from FDA techstocks.com - Understanding the SummarySIZE OF MARKET techstocks.com - News Release 9/15/97techstocks.com - Conference Call Transcript 9/17/97NEWS ITEMS Message 5502463 - clinical trials of the Colormate(TM) TLc - Bilitest(TM) in monitoring bilirubinemia in several hospitals in South Africa , including Baragwanath Hospital (Johannesburg) and King Edward Hospital (Durban). Also up to date info on Memorandum of Understanding ("M.O.U.") with the International Health Exchange Center, Ministry of Health ("M.O.H.") of the People's Republic of China in Beijing.Message 5502461 - Information on Chromatics' medical marketing, sales and distribution support division .Message 5486395 - News - 8/13/98 - Chromatics' New Non-Invasive Bilirubin Infant Jaundice Monitoring Device Launches in Europe .Message 4963834 - News - 6/22/98 Chromatics Color Sciences Signs Memorandum of Understanding with China's International Health Exchange Center, Ministry of Health - Also Announces Letter of Intent With China National Medical Equipment and Supplies Import and Export Corporation, Ministry of HealthMessage 4682791 - News - 6/2/98 - Sinomed Exhibition, Beijing, China , June 9 to June 12, 1998 and presentation of the Colormate TLc-BiliTest at the Beijing Children's Hospital and the Beijing Obstetrics and Gynecology Hospital on June 15 and 16, 1998 respectively.Message 4313818 - News - 5/4/98 - OFFICIAL INTRODUCTION OF THE DEVICE AT PAS CONVENTIONMessage 3727228 - News - 3/16/98 - Launch of new hand-held and console model at the 1998 Pediatric Academic Societies' Annual International Exposition in New Orleans May 1-5, 1998Message 3033543 - News - 12/23/97Message 3033819 - Info on Dr. MaiselsMessage 3033873 - Info on Dr. Holzman
