BIOFIELD BBE BREAST CANCER TEST CLINICALS WILL BEGIN IN THIRD QUARTER
This article was originally published in The Gray Sheet
Executive Summary
BIOFIELD BBE BREAST CANCER TEST CLINICALS WILL BEGIN IN THIRD QUARTER, the privately held Roswell, Georgia-based firm said May 26. The 1,000-patient study will be conducted in at least five centers; the company hopes to submit the results to FDA in 1995. Though the device is in Class III, the clinicals will not require an investigational device exemption, the firm said, because the device is considered to pose a non-significant risk.