Digirad Corp Receives U.S. FDA 510(k) Market Clearance For Expanded Uses Of ergo(TM) Imaging System

Digirad Corp announced that it has received U.S. FDA 510(k) market clearance to further expand the clinical flexibility of the ergo Imaging System for applications throughout the hospital, including the areas of nuclear medicine, surgery and women's health. The clearance includes indications for lymphatic scintigraphy and parathyroid scintigraphy, both nuclear diagnostic imaging tests, and to aid in the evaluation of lesions in the breast and other small body parts. The ergo can also be used intra-operatively when protected by sterile drapes. When used for breast imaging, the ergo System is indicated to serve as an adjunct to mammography or other primary breast imaging modalities.