September 23, 2008 - Digirad Corp. yesterday announced FDA clearance of its nSPEED reconstruction software, to be used in its imaging systems for SPECT procedures at either half-time and/or half count densities with parallel and non-parallel hole collimators, reportedly resulting in quicker exams, improved image quality and less radiation exposure.
With nSPEED, Digirad Cardius solid-state dedicated cardiac systems can now perform cardiac SPECT imaging procedures in as little as three minutes or with one-half the required pharmaceutical dosages. Data that the company submitted to the FDA was obtained from a 448-patient, 10-center evaluation using Digirad's single, dual and triple-head Cardius cameras.
In June 2008, the American Society for Nuclear Cardiology (ASNC) issued new technology-standards for SPECT image acquisition and processing, and stated, "For new software methods specifically designed for reduced acquisition times and/or lower count density images, cardiac count density should be in accordance with that specified in or implicit to the method's 510(k) FDA approval."
According to Digirad, nSPEED reconstruction software enables SPECT procedures that meet new ASNC technology standards.
For more information: www.digirad.com