The initial regulatory application for an adjunctive diagnostic test to mammography has been given the green light by the Food and Drug Administration. Computerized Thermal Imaging said Dec. 17 that the FDA has approved the first regulatory module of a premarket approval (PMA) application for the company's breast cancer detection system. The module, submitted in September, is the first of five that will be reviewed by the agency.
The Layton, UT-based company is seeking approval for the system, which uses a heat-sensitive camera to record thermal images of breast tissue. Computer algorithms then process the images. The company hopes the system will be used as a complement to mammograms and clinical examinations.
Under the modular approach, CTI will offer portions of data to the FDA over a period of time. A CTI spokeswoman said that the company did not have a long-term deadline for when all five modules must be in to the FDA.
By AuntMinnie.com staff writersDecember 20, 1999
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