Optical breast imaging firm DOBI Medical International of Mahwah, NJ, said it plans to increase the number of U.S. sites participating in the clinical trial of its ComfortScan breast imaging system from 10 to at least 20 sites.
ComfortScan is a noninvasive, nonionizing device that uses light-emitting diodes and gentle external pressure to identify breast angiogenesis, which has been linked to the growth and development of malignant tumors. The trial is the final element of the company's premarket approval (PMA) application to the Food and Drug Administration.
The study is designed to analyze the capabilities of the ComfortScan system as an adjunct to mammography designed to aid doctors in diagnosing unidentified breast lesions.
By AuntMinnie.com staff writers
June 1, 2005
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