Digirad Corporation out of Poway, California has received 510(k) clearance from the FDA to market the nSPEED® image reconstruction software for use on the company’s SPECT (single photon emission computed tomography) systems.
From the nSPEED brochure:
nSPEED models the depth-dependent point response function in an iterative reconstruction algorithm (OSEM), thus enabling depth-dependent resolution recovery and improving chamber contrast in cardiac SPECT images. nSPEED has been shown to significantly improve the resolution of SPECT images as compared to standard reconstruction methods. These improvements enable the reduction of acquisition time or patient dose while maintaining image quality as compared to conventional reconstruction methods that do not use depth-dependent resolution recovery.
More details from the press release:
For example, 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. Supporting 510(k) documentation submitted to the FDA was based on data obtained from a 448-patient, 10-center evaluation using Digirad’s single, dual and triple-head Cardius cameras.
Digirad Chief Executive Mark Casner stated: “Our nSPEED software represents a new benchmark for performing nuclear SPECT studies that meet the new standards recently issued by the American Society of Nuclear Cardiology. In addition, with nSPEED which is an advanced 3D-OSEM reconstruction program, the acquisition times for, and count densities of, cardiac SPECT images represent a 50 percent improvement over specifications in prior ASNC guidelines.”
On June 18, 2008, the American Society for Nuclear Cardiology (ASNC) issued new technology-standards for SPECT image acquisition and processing. This standard 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.”
Press release: Digirad Corporation Receives FDA 510(K) Clearance for nSPEED® Reconstruction Software for Improved Image Quality in Less Time with Less Radiation
Product brochure: nSPEED… (.pdf)
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