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Digirad Corp. (DRAD) Receives FDA 510(k) Clearance for Expanded Uses of ergo Imaging System

Digirad is a leading provider of diagnostic imaging products, as well as personnel and equipment leasing services. The ergo Imaging System is the company’s most advanced nuclear medicine camera featuring the Large Field of View (LFOV) solid-state detector. Lightweight and portable, it can be easily be moved throughout any health facility, maximizing its usefulness and operational cost.

The company reported today 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 Food and Drug Administration clearance included indications for lymphatic scintigraphy and parathyroid scintigraphy, both nuclear diagnostic imaging tests. The approval also covered aiding in the evaluation of lesions in the breast and other small body parts. In breast imaging, the ergo serves as an adjunct to mammography. The ergo can also be used intra-operatively when protected by sterile drapes.

Digirad’s ergo Imaging System is a perfect example of the company’s continuous efforts to provide its customers with better ways to attain improvements in outcomes, both clinically and financially. It is leading physicians to re-think how, when, and where imaging systems are used.

For additional information about Digirad, visit www.digirad.com

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