Modulated Imaging receives FDA clearance for its new Clarifi imaging system

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Modulated Imaging, a company developing optical imaging solutions powered by spatial frequency domain imaging (SFDI) for noninvasive assessment of tissue health, announced today that it has received FDA 510(k) clearance for its new medical device, the Clarifi imaging system.

Clarifi is the first and only commercialised 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 haemoglobin 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 non-invasive system that measures tissue oxygen saturation (StO2), oxyhaemoglobin (HbO2), and deoxyhaemoglobin (HbR). In addition, it is the first non-invasive diagnostic technology to quantitatively display total haemoglobin levels in superficial (0­­–1mm) and subsurface (1.5–3mm) layers—HbT1 and HbT2, respectively. Clarifi’s exclusive capabilities gives clinicians greater understanding of tissue perfusion, oxygen supply, and utilisation. 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.

Optimised 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 225mmx300mm—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 haemoglobin delivery to superficial and subsurface tissue in any region of interest, with clarity and confidence.

“The ability to separately quantify and display in total haemoglobin and distribution in superficial and subsurface layers of tissue is a significant advancement,” said Anand S Patel, chief of Interventional Radiology at Providence Little Company of Mary Medical Center, Torrence, USA. “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, medical director at the Crozer Wound Healing Center in Springfield, USA.

“Clarifi is a powerful example of how cutting edge optical imaging and computational technologies can be combined to create new, accessible tools for Precision Medicine,” said Bruce Tromberg, director of the Beckman Laser Institute and Medical Clinic at UC Irvine, Irvine, USA. “Clarifi delivers more insight into oxygen delivery, availability, and utilisation at the microvascular level than any other diagnostic technology. Unlike other optical imaging devices used for assessing tissue, Clarifi quantifies and displays haemoglobin concentration and distribution in the superficial and subsurface. Every person is different, and this new information reveals individual biomarkers that clinicians can use to optimise health and clinical outcome for each patient.”

“We’re proud to be able to provide meaningful information that advances patients’ health and wellness. FDA clearance is a major milestone for our company, and for the patients and physicians within the vascular treatment communities,” said David Cuccia, Modulated Imaging’s CEO and CTO. “Clarifi can lead to significant preventive care actions as well as over US$6 billion per year in savings to the US healthcare system.”

The Clarifi imaging system demonstrates Modulated Imaging’s continuing mission to deliver technology that provides clinically actionable information for early intervention, enabling caregivers to prevent the onset or escalation of conditions related to circulatory compromise.

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

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