LiverMultiScan imaging device receives FDA 510(K) clearance for detecting early liver disease- Perspectum Diagnostics
Perspectum Diagnostics has announced that its LiverMultiScan imaging device, which can detect early liver disease using magnetic resonance imaging (MRI), has been given 510(k) clearance from the FDA. The platform is now positioned for marketing in the United States and set for a formal launch at the 2015 American Association for the Study of Liver Disease (AASLD) Liver Meeting.
LiverMultiScan is currently the only imaging test cleared to detect early-stage liver disease. The technology offers a quantitative liver assessment in a non-invasive 15-minute MRI scan. Analysis is based on assessment of native properties of liver tissue, accurate measurement of liver fat and other metrics without the need for additional diagnostic technologies or contrast agents.