DOBI Medical International (Mahwah, New Jersey) said that if its current PMA clinical study of the ComfortScan system is modified, there may be an opportunity to demonstrate more accurate results in pre-menopausal women.

Consequently, the company said it plans to discuss possible changes to its current clinical study protocol with the FDA. In the event the FDA concurs with this approach, DOBI said it may be necessary to enroll additional patients in its clinical study, thus extending the enrollment phase of the study into 3Q06.