To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Grants Conditional Premarket Application Approval For Glucowatch URL: http://www.pslgroup.com/dg/14EBFE.htm Doctor's Guide December 7, 1999
GAITHERSBURG, MD -- December 7, 1999 -- Cygnus, Inc. announced that its premarket approval application (PMA) for the GlucoWatch(R) monitor received an unanimous recommendation for approval with conditions by the Food and Drug Administration's (FDA) Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee. Cygnus will work with the FDA regarding the conditions indicated by the Advisory Committee. The Advisory Committee suggested three conditions for approval. The first is an education program, about which the Company has already been in discussion with the FDA. In order to satisfy the second condition, the labeling will be revised in accordance with recommendations to be given to the FDA by the Committee. Third, the Committee suggested post-market study of detection of hypoglycemia and hyperglycemia. "We're pleased with the Advisory Committee's favorable vote and we look forward to finalizing the remaining items with the FDA," stated John C. Hodgman, Chairman, President and Chief Executive Officer of Cygnus. "The GlucoWatch monitor is a powerful and unique tool that has the potential to provide glucose information that has previously been unavailable. We believe that the frequent and automatic measurements can provide new insights about acute trends and long-term patterns of glucose fluctuations. We proposed a conservative label to the FDA to allow people with diabetes and their diabetes care teams to gain experience with, and confidence in, this new device." The GlucoWatch monitor provides frequent, automatic and non-invasive glucose measurements and is intended for detecting trends and tracking patterns in glucose levels in adults, 18 years and older, who have diabetes. The device is intended for use at home and in health care facilities as an adjunctive device to supplement, not replace, information obtained from standard home blood glucose monitoring devices. Following a three-hour warm-up period and calibration from a finger stick blood measurement, the device is capable of providing up to three non-invasive glucose measurements per hour for 12 hours. In addition, the GlucoWatch monitor has the capability to alert users when glucose levels are too high or too low. These situations may be hard to identify with regular glucose testing alone. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.