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In Brief: Biofield Alexa 1000

This article was originally published in The Gray Sheet

Executive Summary

Biofield Alexa 1000: Premarket approval application for the non-invasive system for diagnosing suspicious breast lesions will undergo expedited review at FDA, the Atlanta-based firm says in a Dec. 30 release. Data supporting the application are derived from a recently completed multicenter trial involving about 1,300 patients presenting with suspicious breast lesions detected by x-ray mammography or physical examination. If approved, the Alexa 1000 will be marketed in the U.S. through the firm's direct sales force...
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