Modulated Imaging Receives FDA Clearance for its New Clarifi Imaging System

Modulated Imaging, a leader in optical imaging solutions powered by Spatial Frequency Domain Imaging (SFDI) for noninvasive assessment of tissue health, has received FDA 510(k) clearance for the Clarifi Imaging System.

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.

Clarifi is a non-contact noninvasive system that measures tissue oxygen saturation (StO2), oxyhemoglobin (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 gives clinicians greater understanding of tissue perfusion, oxygen supply and utilization. This 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 available – 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,” said 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," said Jeffrey Lehrman, DPM, medical director at the Crozer Wound Healing Center in Pennsylvania.

The company is currently ramping up production of the Clarifi imaging system and expects to start fulfilling orders by the end of Q4.