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

To: JanyBlueEyes who wrote (1277)	3/9/1998 4:57:00 PM
From: JanyBlueEyes	Read Replies (3) \| Respond to of 5736

Clinical Trials - Competition >>Do you realize that SpectRX clinicals are under way now, that they should* be filing for FDA approval around June, with the go ahead expected around Oct-Nov.* ======= As of October 2, 1997 clinicals were still in the planning stage at Healthdyne. From a Spectrx press release dated October 2, 1997 : .....The BiliCheckTM may not be sold in the U.S. without FDA approval. Healthdyne Technologies plans to conduct U.S. clinical trials required for FDA 510(k) approval......... ======= To obtain the appropriate amount of data to submit to the FDA takes alot of time. If there is not enough data the FDA will reject it. From exchange2000.com - Timeline for CCSI to conduct clinicals and submit to FDA. The first phase of testing in 1988 and 1989 resulted in a positive feasibility study demonstrating that the Colormate(TM) II System skin color measurements corresponded in direct ratio to the laboratory reports of the blood samples drawn. The second phase, which was concluded in November 1992, studied a larger volume of patients and demonstrated the same results. In October, 1993, the Company and Mt. Sinai Hospital published the research results to that date. From October 1993 to April 1996, the Company and Mt. Sinai conducted the third phase of clinical testing involving the compiling of certain additional clinical data relating to expanded testing on a larger group of patients, with emphasis on skin color measurement at birth and while under phototherapy, (the current standart treatment for the disease). In November 1996, the Company filed an application with the FDA for commercial use of its technology for certain medical applications.-endIn April, 1997 the FDA requested additional information from CCSI. On July 30, 1997 - FDA approval. ======= From fda.gov - FDA annual report Under section 510(k) of the law, more than 90% of devices are cleared for marketing when their manufacturer demonstrates they are substantially equivalent to an already-marketed device. To do this, the company submits to FDA a "premarket notification," generally referred to as a "510(k)," in which it justifies its claim for substantial equivalence. Two years ago we succeeded in eliminating a massive backlog of 2,000 overdue 510(k)s. Since then, we have not only prevented the buildup of a new backlog, but have made great strides in reducing the time it takes to process these submissions. In Fiscal Year 1997, the average review time was 97 days, compared to a peak of 184 days in 1994.