FDA clears PEM Technologies' breast compression device:
This article was originally published in Clinica
Executive Summary
PEM Technologies has received 510(k) clearance to market its device for applying controlled compression during scintigraphic breast imaging. The device, which is covered by US and international patents, supports, positions and immobilises the breast during examinations involving injectable agents. The Bethesda, Maryland, company, which has developed PET scanners optimised for breast imaging, says that several investigators have shown that unless breast compression is applied, small early cancers can be missed.