Mediscience Technology Corp Qualified by FDA for Reduced or Waived Fees and Expedited 3rd Party Review Process on Its Medical Device 510K Submissions.Business Editors/Health/Medical Writers BIOWIRE2K CHERRY HILL, N.J.--(BUSINESS WIRE)--Dec. 17, 2003 Mediscience Technology Corp. (MTC mtc - A Modula-2 to C translator. ftp://rusmv1.rus.uni-stuttgart.de/soft/Unixtools/compilerbau/mtc.tar.Z. ), (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :MDSC MDSC Modulated Differential Scanning Calorimetry MDSC Myeloid Derived Suppressor Cell (tumor related) MDSC Maximum-Distance Separable Code MDSC Management Data Service Center MDSC Meta Data Server Cluster ) of Cherry Hill, New Jersey, a developer of imaging technology for molecular detection of cancer and physiological change, announced: on December 11, 2003 the 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. , after review, qualified the Company under MDUFMA MDUFMA Medical Device User Fee and Modernization Act (The Medical Device User Fee and Modernization Act of 2002) allowing both reduced or waived FDA fees for its 2004 medical device 510K market approval submissions." and Company participation in expedited FDA review through FDA clinical inspections conducted independently by third party FDA approved "accredited accredited recognition by an appropriate authority that the performance of a particular institution has satisfied a prestated set of criteria. accredited herds cattle herds which have achieved a low level of reactors to, e.g. " persons, directly employed by Mediscience. President and Chief Operating Officer Chief Operating Officer (COO) The officer of a firm responsible for day-to-day management, usually the president or an executive vice-president. Michael Engelhart stated, "we are making steady progress in all aspects of our business and continue to expand our leadership in the Optical Biopsy field." NOTE: Web Page: MEDISCIENCETECH.com INVESTOR NOTICE: Certain of the matters discussed in this announcement contain forward-looking statements that involve material risks to and uncertainties in the company's business that may cause actual results to differ materially from those anticipated by the statements made herein. Such risks and uncertainties include among other things, the availability of financing, the company's ability to implement its long-range business plan for various applications of its technology; the company's ability to enter into agreements with any necessary marketing and/or distribution partners; the impact of competition, the obtaining and maintenance of any necessary US regulatory clearances applicable to applications of the company' technology; and management of growth and other risked and uncertainties that may be detailed from time to time in the company's reports filed with the Securities and Exchange Commission. This disclosure is intended to satisfy: SEC Section 6, 6.01 Regulation FD, disclosure and Section 7 and 7.0 as well as all applicable and presently effective Sarbanes-Oxley disclosure requirements under Regulation G. |
|
||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion