Biofield U.S. trials for non-invasive breast cancer diagnosis system to wrap up in 1996.
This article was originally published in The Gray Sheet
Executive Summary
BIOFIELD NON-INVASIVE BREAST CANCER DIAGNOSTIC SYSTEM U.S. TRIALS are expected to be completed during 1996, the company says in a prospectus for an initial public offering. Initiated in March 1995, the six-center study is slated to involve 1,300 women with suspicious lesions detected by x-ray mammography or physical examination. Data from the trial will form the basis of a premarket approval application, which FDA has pledged to review on an expedited basis. The study is being conducted under approval from hospital investigational review boards, which deemed the product a non-significant risk device, the prospectus reports.