CardiArc seeks clearance for SPECT

Cardiac imaging device developer CardiArc reported that it submitted a premarket notification 510(k) application with the Food and Drug Administration for a SPECT imaging device last month.

The Lubbock, TX-based CardiArc said the SPECT device has been specifically designed for use in outpatient settings. In its present configuration, the device fits within a 6 x 7-foot exam room, requires no room modifications for installation or operation, and uses U.S. standard voltage.

By staff writers
November 23, 2005

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