SOURCE: Digirad


January 31, 2013 07:30 ET

Digirad Corporation Receives U.S. FDA 510(k) Market Clearance for Expanded Uses of ergo™ Imaging System

POWAY, CA--(Marketwire - Jan 31, 2013) - Digirad Corporation (NASDAQ: DRAD), a leading provider of diagnostic imaging products, and personnel and equipment leasing services, today announced that it 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, Chief Executive Officer of 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 said. "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.

About Digirad

Digirad is a leading provider of diagnostic imaging products, and personnel and equipment leasing services. For more information, please visit Digirad® is a registered trademark of Digirad Corporation.

About ergo™ Imaging System

The ergo™ Imaging System is Digirad's most advanced nuclear medicine camera featuring the Large Field of View (LFOV) solid-state detector. The system provides superior image contrast and clarity for general imaging. Five easy to change, high performance collimator options provide the capability to provide outstanding imaging quality for a wide range of procedures with energy ranges from 50 to 350 keV. Designed for versatility, the open gantry, long 48" reach and multiple compound motions provide enhanced positional flexibility to address various applications and patient settings. Lightweight and portable, the ergo™ Imaging System can be easily moved throughout the hospital maximizing the system's utility and convenience. The ergo™ Imaging System delivers improved clinical outcomes, imaging without boundaries and a significant return on investment.

Contact Information

  • Investor Contact:
    Matt Clawson
    Allen & Caron

    Company Contact:
    Todd P. Clyde
    Chief Executive Officer