Clarifi™ is a user-friendly, noninvasive, non-contact device that measures critical hemoglobin biomarkers in tissue over a wide area — up to a full size 15 foot.

Powered by a proprietary optical imaging technique — spatial frequency domain imaging (SFDI) — Clarifi™ offers clinicians a fast, reliable, objective method of assessing tissue oxygen saturation and hemoglobin concentration and distribution in patients with compromised circulation. Oxygenation is a key biomarker to identify areas of compromised tissue. Clarifi™ accurately quantifies tissue oxygen saturation and hemoglobin concentration and distribution, which may help clinicians identify patients who are at-risk of vascular complications. 

An ounce of prevention is priceless

Powered by an advanced imaging technology known as SFDI, Clarifi™ quantifies and displays 5 key biomarkers:*

• Tissue oxygen saturation (StO₂)
• Oxyhemoglobin (HbO₂)
• Deoxyhemoglobin (HbR)
• Papillary dermis hemoglobin (HbT₁)
• Reticular dermis hemoglobin (HbT₂)

Tissue oxygen saturation is a necessary, but insufficient indicator of tissue health. The ability of Clarifi™ to measure hemoglobin concentration and distribution in the papillary and reticular dermis reveals otherwise unavailable insight into the delivery of oxygen-carrying hemoglobin to the capillary network.

Equipped with this new information, Clarifi™ helps clinicians identify at-risk patients earlier, quantify the nature and level of their risk, and target care to prevent complications.

*This information is intended for general guidance only and should not be interpreted as specific medical, diagnostic, or therapeutic recommendations.

Clinical study: “Near-instant noninvasive optical imaging of tissue perfusion for vascular assessment”

A study published by Weinkauf et al. (Oct. 2018) in the Journal of Vascular Surgery “aimed to evaluate the ability of spatial frequency domain imaging (SFDI) … to assess lower extremity blood supply” compared to other noninvasive vascular tests including ankle-brachial index (ABI), toe-brachial index (TBI)  and pedal Doppler waveforms. The study included 47 subjects with and without diabetes.

Findings included:

• SFDI ratio identifies peripheral artery disease (PAD) in subjects with diabetes:
  • HbT₂/HbT₁ ratio is high for clinically validated PAD
  • ABI correlation to PAD is poor in subjects with diabetes
  • SFDI correlates with TBI in subjects with diabetes

• Evidence of elevated StO₂ and reduced HbT₁ due to diabetes-related arterio-venous shunting:
  • Conditions result in under-extraction of oxygen and helps identify ulceration risk that ABI cannot identify.
  • Demonstrated noninvasive measurement of circulatory shunting due to diabetes.

The study concluded “SFDI is a feasible, rapid, and easy-to-use widefield measurement of perfusion in a clinical setting. This first-of-use study suggests that the technology has potential to evaluate lower extremity perfusion in people with and without diabetes.”

Clarifi™ is designed for use throughout the continuum of care

Clarifi™ is designed to help clinicians identify compromised circulation, which may indicate that a patient is at risk for ulceration, infection or amputation. As a fully integrated system that is easy to operate, Clarifi™ supports consistency in practice, enables early detection and intervention, and has the potential to improve outcomes and help to reduce costs across the continuum of care.

The Clarifi™ Imaging System is easy and affordable for clinicians to integrate into their practice and supported by reimbursement (CPT code 0061U). Clarifi™ is a powerful new point-of-care imaging system designed to help clinicians identify microvascular complications.