Modulated Imaging gets FDA nod for optical imaging unit

Optical imaging technology developer Modulated Imaging has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Clarifi optical imaging system.

Clarifi uses spatial frequency domain imaging (SFDI), a patented technology based on structured light that's designed to help clinicians assess tissue function and compromised circulation. It measures oxygenation and hemoglobin in superficial tissue, aiding in the assessment, management, and treatment of conditions such as peripheral vascular diseases, diabetic foot ulcers, burns, skin flaps, and chronic wounds, the company said.

Modulated Imaging said it is now ramping up production of Clarifi and it expects to begin fulfilling orders by the end of the fourth quarter.

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