FDAnews Device Daily Bulletin
Medical Devices / Research and Development

Seno Completes Pivotal Breast Imaging Study

Oct. 1, 2015
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Seno Medical Instruments has completed the final phase of its U.S.-based Pioneer pivotal study of the Imagio breast imaging system.

The 2,100-patient study is evaluating the system’s accuracy in determining whether a breast mass is cancerous by comparing its sensitivity and specificity versus grayscale ultrasound. The goal is to help women avoid negative biopsy procedures.

The Imagio system is designed to identify the presence of abnormal blood vessels and the relative drop in oxygen in the blood, the two functional hallmarks of cancer.

The results, which will a premarket approval application with the FDA, will be presented at the 2015 European Society of Breast Imaging Annual Scientific Meeting, Oct. 2-3, in London. — Michael Cipriano