CT laser mammography developer Imaging Diagnostic Systems has been notified by the Food and Drug Administration that an initial review of its pre-market approval (PMA) application for its CT breast imaging system has been judged to be suitable for filing. As such, the FDA will now conduct an in-depth evaluation of the safety and effectiveness of the device to determine final approval, according to the Fort Lauderdale, FL-based vendor.
By AuntMinnie.com staff writersJune 18, 2003
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