www.fdanews.com/articles/187849-fda-clears-modulated-imagings-clarifi-imaging-system
FDA Clears Modulated Imaging’s Clarifi Imaging System
August 2, 2018
The FDA granted 510(k) clearance to Modulated Imaging’s Clarifi imaging system, used for noninvasively assessing tissue function.
The device quantifies and displays hemoglobin concentration and its distribution and reveals individual biomarkers for physician use.
The imaging system measures oxygenation and hemoglobin levels in order to treat burns, foot ulcers, chronic wounds, peripheral vascular diseases and other conditions.
