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Digirad Corp. (DRAD) Garners CE Mark Approval for its Cardius® X-ACT Imaging System

Digirad, a leading supplier of diagnostic imaging products and personnel and equipment leasing services, announced that it has been granted Conformitee Europeene (CE) Mark approval for the Cardius® X-ACT imaging system. This advanced, solid-state camera system makes earlier disease detection possible through increased diagnostic accuracy. Obtaining CE Mark approval will enable Digirad to manufacture and market the Cardius X-ACT system in the European Union.

Digirad additionally announced that it has signed a distribution agreement with Epsilon Elektronik, a Turkish company that is part of the Istanbul-based Bozlu Group. This agreement is part of Digirad’s strategy to build out a targeted international selling network. Digirad signed a similar agreement last year with Southern Scientific, a UK-based company that is already implementing the use of an ergo™ portable solid-state camera at the Manchester Royal Infirmary.

Part of Digirad’s international growth strategy is to build a network of top distributors in targeted markets, where the demand for flexible imaging products like the X-ACT is steadily growing. The company projects that the flexibility, lower overall costs and potential for improved clinical outcomes will make its expanding line of camera products attractive in the international market. Securing other distribution agreements will be key in Digirad’s endeavor to more meaningfully tap into burgeoning markets for dedicated cardiac and portable nuclear imaging.

The Cardius X-ACT imaging system considerably reduces artifacts in images caused by overlying tissues. This is accomplished through X-ACT’s low-dose volume-computed tomography attenuation correction system. Digirad anticipates that its X-ACT imaging system, ergo™ flexible imaging camera and future camera models will be well received in the international market, providing new clinical information that will increase the benefit of nuclear cardiology procedures, raise industry standards for SPECT system performance and improve outcomes at an accessible price point.

Digirad previously received FDA clearance to market the Cardius X-ACT imaging system in the United States and also obtained CE Mark and FDA clearance to market the ergo portable solid-state camera.

For further information about the company, visit www.digirad.com