Imaging software developer Syntermed has been awarded 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Emory Cardiac Toolbox version 4.0 nuclear cardiac software.
Emory Cardiac Toolbox 4.0 includes SmartReport, a cloud-based nuclear cardiology reporting tool using decision support, the firm said.
The software acquires data wirelessly from electrocardiogram-gated myocardial perfusion SPECT studies, automatically reconstructs the data, then analyzes and converts it into quantitative parameters or factors of abnormality. The data are then submitted to a decision-support system that is continuously updated with the latest scientific and clinical knowledge to reach an impression of the patient's heart status, according to the company.
Reports are accessible via the cloud and can be fully integrated with electronic medical records. The 510(k) clearance also covers the quantification of myocardial blood flow and coronary flow reserve.
Emory Toolbox 4.0 will be launched on June 8 at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) annual meeting.
