Optical imaging developer DOBI Medical International reported that it plans to discuss possible changes to the current clinical study protocol for its ComfortScan system with the Food and Drug Administration.
The Dynamic Optical Breast Imaging (DOBI) ComfortScan system is a noninvasive adjunct device to mammography uses near-infrared light and external pressure to detect angiogenesis in suspicious areas of the breast.
The Mahwah, NJ-based vendor said that recently collected ComfortScan clinical data indicates that, if its current premarket authorization (PMA) clinical study is modified, there may be an opportunity to demonstrate more accurate results in premenopausal women.
The firm said that it anticipates the possibility of amending its study protocol to reflect preliminary results from data obtained at overseas clinical sites, but that it will discuss this with the FDA prior to amendments.
DOBI said that it expanded the number of clinical sites participating in its PMA clinical trial to 23 U.S. sites last year and that more than 1,100 patients have been enrolled.
By AuntMinnie.com staff writers
February 2, 2006
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DOBI releases ComfortScan 2.0 software, January 19, 2006
Road to RSNA, DOBI Medical International, November 7, 2005
DOBI signs Beardsworth for PMA trial, November 3, 2005
DOBI reveals China strategy, October 25, 2005
DOBI inks research deal with Dartmouth, October 13, 2005
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