NOT TRUE, THEY UPDATED CTLM WITH NEW SOFTWARE. IT IS NOT THE SAME DEVICE THEY APPLIED THE FIRST TIME TO FDA. ALSO FDA APPROVED FOR DOT HERE THE NEWS LINK http://investorshub.advfn.com/boards/read_msg.aspx?message_id=76875925 ANOTHER THING FDA GAVE EXPORT CERTIFICATION. ALSO THE COMPANY HAS CE MARKING CERTIFICATE ACCEPTED IN 32 COUNTRIES IN EUROPE, PLUS CHINA, RUSSIA, CANADA, CERTIFICATIONS. THEY MADE CLINICAL TRIALS IN USA AND OVERSEAS BETWEEN 2006 AND 2010 13,000 PEOPLE TESTED BY CTLM. CURRENTLY DOCTORS ARE USING IMDS. THEY DON'T HAVE PROBLEM TO SELL INTERNATIONALLY. SO LAST QUARTER THEY MADE AGREEMENT WITH MEXICO TO SELL 5 OF THEM. NOW IT IS FINAL STAGE FOR PRE-MARKET APPROVAL BY FDA.