Modulated Imaging, an Irvine, California-based imaging vendor, announced this week that its Clarifi Imaging System has received FDA 510(k) clearance.
Clarifi uses Modulated Imaging’s patented Spatial Frequency Domain Imaging technology to assess tissue function by measuring oxygenation and hemoglobin levels. The noninvasive solution is used to manage and treat peripheral vascular diseases, foot ulcers, burns, chronic wounds and other conditions.
“We’re proud to be able to provide meaningful information that advances patients’ health and wellness,” David Cuccia, PhD, Modulated Imaging’s CEO and CTO, said in a prepared statement. “FDA clearance is a major milestone for our company, and for the patients and physicians within the vascular treatment communities.”
“Clarifi delivers more insight into oxygen delivery, availability, and utilization at the microvascular level than any other diagnostic technology,” Bruce Tromberg, PhD, director of the Beckman Laser Institute and Medical Clinic at the University of California, Irvine, said in the same statement. “Unlike other optical imaging devices used for assessing tissue, Clarifi quantifies and displays hemoglobin concentration and distribution in the superficial and subsurface. Every person is different, and this new information reveals individual biomarkers that clinicians can use to optimize health and clinical outcome for each patient.”