Modulated Imaging, an Irvine, Calif.-based provider of optical imaging solutions powered by spatial frequency domain imaging (SFDI) for noninvasive assessment of tissue health, has received FDA 510(k) clearance for its new medical device, the Clarifi Imaging System.

According to the company, Clarifi is the first and only commercialized diagnostic medical device to use SFDI, a patented technology based on structured light, that helps clinicians assess tissue function and compromised circulation by measuring oxygenation and hemoglobin levels in superficial tissue. This essential information can be used in the assessment, management and treatment of several challenging conditions, including peripheral vascular diseases, diabetic foot ulcers, burns, skin flaps, and chronic wounds.

The non-contact, noninvasive system measures tissue oxygen saturation (StO2), oxyhaemoglobin (HbO2), and deoxyhemoglobin (HbR). In addition, it is the first noninvasive diagnostic technology to quantitatively display total hemoglobin levels in superficial (0-1mm) and subsurface (1.5-3 mm) layers—HbT1 and HbT2, respectively. Clarifi’s exclusive capabilities give clinicians greater understanding of tissue perfusion, oxygen supply, and utilization. This critical information can be used for earlier identification of patients who are at risk for developing wounds, and to guide clinical interventions to prevent their onset or escalation.

Optimized for seamless integration into a variety of care delivery environments, Clarifi is designed to address shortcomings of existing spectral imaging systems (multispectral and hyperspectral) by incorporating structured light into the process. Clarifi is smaller, faster, and lighter than its predecessor, Ox-Imager CS, and it offers the largest optical imaging field avail-able—approximately 225 mm x 300 mm—and can image the entire plantar aspect of a foot. The system displays color-coded images of each biomarker to help clinicians assess oxygenation and hemoglobin delivery to superficial and subsurface tissue in any region of interest, with clarity and confidence.

“The ability to separately quantify and display in total hemoglobin and distribution in superficial and subsurface layers of tissue is a significant advancement,” says Anand S. Patel, MD, Chief of Interventional Radiology at Providence Little Company of Mary Medical Center. “Modulated Imaging’s technology should enable us to better diagnose and treat patients with compromised circulation who may be at risk for lower limb diabetic complications, peripheral arterial disease, or similar conditions.”

“With much of our daily practice dedicated to limb salvage, this technology is so exciting because I know it will provide information that will allow us to prevent ulcers before they occur, heal them more efficiently when they do occur, and ultimately limit amputations,” adds Jeffrey Lehrman, DPM, Medical Director at the Crozer Wound Healing Center in Pennsylvania.

For more information, visit Modulated Imaging.