FDA Clears Digirad's Ergo Imaging System

Digirad Corporation (DRAD) 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.

Todd Clyde, COE, Digirad, indicated that the ergo system was always envisioned as a multi-use, portable camera with a wide variety of clinical capabilities and operational efficiencies. The new indications add to the "image without boundaries" concept of the large field, solid-state ergo device.

"The ergo Imaging System is a perfect example of our continuous efforts to provide our customers with new ways to attain further improvements in clinical and financial outcomes," Clyde notes. "The ergo Imaging System allows physicians to rethink traditional practices regarding how and where an imaging system is used. As a leader in diagnostic imaging, we are dedicated to developing and marketing new and innovative products that enhance life by dramatically improving the diagnosis and treatment of disease." The ergo Imaging System provides powerful new solid-state technology substantially raising overall performance capabilities and significantly lowering total lifecycle costs. The Large Field of View (LFOV) camera (12.25" x 15.5") provides ideal utility for a wide range of procedures performed in nuclear medicine or throughout the hospital. The sleek, open gantry/detector design is patient friendly and convenient to image patients sitting up and lying on stretchers or beds. Its lightweight, portable design makes it possible to use in nearly any room or department.

The portable design of the ergo Imaging System offers the potential to increase return on investment, reduce operational costs, and increase study volume over traditional fixed assets.