CCSI INFORMATION PAGE - COLORMATE TLc-BiliTest SYSTEM PRODUCTS, FDA 510K, CONSOLIDATED NEWS RELATED TO BILIRUBIN ASPECT
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Click on any underlined "link" below to view that information.
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COLORMATE TLc-BiliTest SYSTEM PRODUCTS
Message 4329124
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APPROVAL FROM FDA
techstocks.com - Actual 510K Summary from FDA
techstocks.com - Understanding the Summary
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SIZE OF MARKET
techstocks.com - Most Recent Info From Conference Call Dated 6/21/99
techstocks.com - News Release 9/15/97
techstocks.com - Conference Call Transcript 9/17/97
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**BROADCAST NEWS ITEMS & MEDICAL PUBLICATIONS**
PARENTS MAGAZINE JULY 1999
Message 10134200 - New Pain-Free Test For Jaundice
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AP NEWSWIRE STORY
Message 8440697 - 3/21/99 - Mom Develops Infant Jaundice Test
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NEW YORK POST ARTICLE
Message 7848587 - 2/16/99 - Inventor mom curbs tears
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NYC BROADCAST NEWS SEGMENT ON THE TLc-BiliTest
Message 6149233 - 10/16/98 - "If you've ever had a baby, especially a preemie, there's a reasonable chance your child suffered a problem called newborn jaundice and maybe even spent a little time under some special UV lights to treat the problem. You might also remember the painful blood tests your little tyke had to endure. But now there's a better way...."
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ARTICLE IN PEDIATRICS ON A MAJOR STUDY DONE USING CHROMATICS' TLc-BiliTest
Message 5703900 - 9/98 -. "..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......"
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PHYSICIAN'S WEEKLY
Message 4931593 - 6/22/98 - - "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....."
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**NEWS RELEASES FROM THE COMPANY**
MASS MANUFACTURING BEGINS - LEHMAN BROS FINANCING
Message 10105491 - News - 6/14/99 - Chromatics Commences Initial Manufacturing Requirements; Lehman Brothers Provides Equity Financing
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DISTRIBUTION AGREEMENT
Message 10051364 - News - 6/9/99 - Datex-Ohmeda, Inc. and its Ohmeda Medical Division are Granted Exclusive U.S. License for Distribution of Chromatics' Non-Invasive Monitoring System for Infants
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EUROPEAN UNION CE MARK CERTIFICATION
Message 9190111 - News - 4/28/99 - Chromatics Color Sciences Receives European Union CE Mark
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CERTIFICATION FOR INTERNATIONAL DISTRIBUTION
Message 8453565 - News - 3/22/99 - Chromatics Color Sciences Receives Important ISO-9001 and EN46001 Quality Certifications Supporting International Distribution of Infant Monitoring Device
SHIPPING BEGINS
Message 7772213 - NEWS - 2/11/99
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NEW SALES AND HOSPITAL TRAINING STAFF ANNOUNCED
Message 7096059 - News - 1/4/99 - Chromatics Color Sciences Hires McClinton, Forms Sales and Hospital Staff Training Units
Message 5502461 - Information on Chromatics' medical marketing, sales and distribution support division.
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MANUFACTURING AGREEMENT
Message 6270156 - News - 11/3/98 - Chromatics Announces Manufacturing Agreement for Infant Bilirubin Monitor
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CLINICAL TRIALS IN SOUTH AFRICA & CHINA INFO
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.
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EUROPEAN LAUNCH
Message 5486395 - News - 8/13/98 - Chromatics' New Non-Invasive Bilirubin Infant Jaundice Monitoring Device Launches in Europe
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MOU WITH CHINA
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 Health
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EXHIBITION IN CHINA
Message 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.
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OFFICIAL INTRODUCTION OF THE DEVICE AT PAS CONVENTION
Message 4313818 - News - 5/4/98
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ANNOUNCEMENT OF LAUNCH OF NEW MEDICAL PRODUCT
Message 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, 1998
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PROMINENT PEDIATRICIANS ON MEDICAL ADVISORY BOARD
Message 3033543 - News - 12/23/97
Message 3033819 - Info on Dr. Maisels
Message 3033873 - Info on Dr. Holzman |
