DOBI reaches agreement with FDA

Optical imaging developer DOBI Medical International has reached agreement with the Food and Drug Administration on the clinical study the Mahwah, NJ-based vendor will conduct as the final step in a pre-market approval (PMA) application for its ComfortScan breast imaging system.

The study, expected to begin in the third quarter, will take place at about a dozen research sites in the U.S., and will involve up to 600 patients previously referred to biopsy following a suspicious or indeterminate initial finding. At the end of the clinical study, an independent group of researchers will interpret the ComfortScan scans, blinded to the results of the biopsied patients, DOBI said. The study results will be used in the submission of DOBI's fifth and final PMA module.

By AuntMinnie.com staff writers
June 8, 2004

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