FDA Officially Accepts Xillix PMA.XILLIX TECHNOLOGIES(TSE See Tokyo Stock Exchange. TSE 1. See Tokyo Stock Exchange (TSE). 2. See Toronto Stock Exchange (TSE). : XLX ) Xillix's President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. Pierre Leduc announced today that the Company has received notification from the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) that the Company's Premarket Approval (PMA) application for the Xillix(R) LIFE-Lung(TM) system has been officially filed on first submission. The Company submitted a PMA application to the FDA in December, 1995 for Xillix LIFE-Lung, a device that has shown in clinical trials to improve a physician's ability to detect early lung cancer by 171 percent over conventional white light bronchoscopy Bronchoscopy Definition Bronchoscopy is a procedure in which a cylindrical fiberoptic scope is inserted into the airways. This scope contains a viewing device that allows the visual examination of the lower airways. . "We are very pleased that the FDA has made a determination that the PMA is sufficiently complete to permit a substantive review, and is, therefore, suitable for filing" says Mr. Leduc. "This is the first major milestone towards obtaining FDA approval in the U.S. market. It is also a major achievement for Xillix to be granted a fileable status on its first submission." Xillix Technologies Corp. is a medical devices company engaged in the research, development and commercialization of medical imaging products which aid in the earlier detection of cancer. -0- The Company is listed on the Toronto Stock Exchange Toronto Stock Exchange (TSE) Canada's largest stock exchange, trading approximately 1,200 company stocks and 33 options. under the trading symbol "XLX". CONTACT: Xillix Technologies Corp. Laurie McMichael Manager, Communications and Investor Relations (604) 278-5000 (604) 278-3356 (FAX) lmcm@xillix.com |
|
||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion