A Medical Device Daily

Digirad (Poway, California), a developer of medical diagnostic imaging products, reported that it has received 510(k) clearance from the FDA to market its Cardius X-ACT imaging system.

Cardius X-ACT is a rapid cardiac SPECT/VCT imaging system that features a low-dose volume-computed tomography (VCT) attenuation correction system that significantly reduces artifacts in the images caused by overlying tissues increasing interpretive ease and accuracy.

The X-ACT approach takes advantage of the 24 inch-wide detector array, eliminating truncation and generating what Digirad terms "high-precision transmission maps, improving the overall quality of SPECT studies."

The company said the X-ACT attenuation correction system "offers high accuracy, fast acquisition, low dose (5 uSv per study) and superb reliability."

The system's high-speed, triple-head, solid-state design — combined with nSPEED software — allows the combined cardiac SPECT emission and transmission acquisitions to be performed in as little as five minutes. Digiurad said the Cardius X-ACT system "increases diagnostic confidence in nuclear cardiology and raises the standard in the industry for overall SPECT system performance."