Laser breast imaging developer Imaging Diagnostic Systems (IDSI) has submitted a premarket approval (PMA) application with the Food and Drug Administration seeking marketing approval for its computed tomography laser mammography (CTLM) system. The company has received CE Marking, UL listing, ISO 9002 certification, and FDA export certification for the product.
The system visualizes the blood supply of tumors, without the use of x-rays and without breast compression, and is intended for use as an adjunct to mammography for women who have dense breasts and equivocal mammograms. IDSI's PMA application has been divided into five different modules, each of which contained specific information required for the FDA review process. The FDA has accepted the first four modules, according to the Fort Lauderdale, FL-based firm.
By AuntMinnie.com staff writersApril 30, 2003
Related Reading
Imaging Diagnostic Systems adds Berlin site, February 3, 2003
IMDS nets CTLM deal in Dubai, January 23, 2003
IDSI installs CTLM in Berlin, September 12, 2002
IMDS installs CTLM at U.S. site, June 12, 2002
Imaging Diagnostic adds Latin American distributor, April 22, 2002
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