U.S. FDA clears optical imaging system for tissue health assessment

Optical imaging system maker Modulated Imaging (Irvine, CA) has received U.S. FDA clearance for its Clarifi imaging system, which is powered by spatial frequency domain imaging (SFDI) to assess tissue health noninvasively. SFDI, a patented technology based on structured light, helps clinicians assess tissue function and compromised circulation by measuring oxygenation and hemoglobin levels in superficial tissue. This 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.

Related: Modulated Imaging's Cuccia to receive research award at ASLMS

The non-contact and noninvasive system measures tissue oxygen saturation (StO₂), oxyhemoglobin (HbO₂), and deoxyhemoglobin (HbR). In addition, it quantitatively displays total hemoglobin levels in superficial (0–1 mm) and subsurface (1.5–3 mm) layers—HbT1 and HbT2, respectively. Its optical imaging field measures approximately 225 × 300 mm, allowing it to 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.

The company is currently ramping up production of the system and expects to start fulfilling orders by the end of Q4 2018.

For more information, please visit modulatedimaging.com.