Digirad Receives FDA Nod for Cardiac SPECT/VCT Imager

March 26, 2009 - Digirad Corp. has received 510(k) clearance from the FDA to market and manufacture its Cardius X-ACT imaging system.

The Cardius X-ACT is a rapid cardiac SPECT/VCT imaging system that features a low-dose volume-computed tomography (VCT) attenuation correction system that reportedly significantly reduces artifacts in the images caused by overlying tissues increasing interpretive ease and accuracy. The revolutionary X-ACT approach takes advantage of the full 24-inch wide detector array eliminating truncation and generating high-precision transmission maps improving the overall quality of SPECT studies. The X-ACT attenuation correction system is designed to offer high accuracy, fast acquisition, low dose (5 uSv / 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.

Results of an extensive multi-center evaluation of the X-ACT technology will be presented during upcoming events including ACC in Orlando, ICNC 2009 in Barcelona, SNM 2009 in Toronto and ASNC 2009 in Minneapolis.

For more information: www.digirad.com