Cancer Diagnostics

Device firm reaches agreement with FDA on trial of ComfortScan system

Published in Cancer Weekly, July 6th, 2004

Dobi Medical International, Inc., (DBMI) announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding the clinical study the company will conduct as its final step in its premarket approval (PMA) application.

The ComfortScan system, an advanced development stage imaging device, was created to provide a new means for the improved diagnosis of cancer though the detection of abnormal vascularization (angiogenesis) associated with tumors.

Angelo Secci, VP of Clinical Research for the company, stated, "We are confident that the development of our ComfortScan system is ready for the commencement of this final phase of...

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Source: Cancer Weekly (2004-07-06)

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