Technology | Point of Care Testing | January 27, 2017

HyperMed Imaging Inc. Receives FDA Clearance for New HyperView Product

Portable device assesses tissue oxygenation without contacting the patient

HyperMed Imaging, HyperView portable tissue oxygenation measurement system, FDA clearance

January 27, 2017 — HyperMed Imaging Inc. announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for the company’s new medical imaging device called HyperView. The HyperView product is a handheld, battery operated, portable diagnostic imaging device that is used to assess tissue oxygenation without contacting the patient.  The product is intended for use by physicians and healthcare professionals as a noninvasive tissue oxygenation measurement system that reports an approximate value of oxygen saturation (O2Sat), oxyhemoglobin level (Oxy) and deoxyhemoglobin level (Deoxy) in superficial tissue.

The HyperView system displays two-dimensional, color-coded images of tissue oxygenation of the scanned surface. Images and data provide hyperspectral tissue oxygenation measurements for selected tissue regions.  The product is indicated for use to determine oxygenation levels in superficial tissues for patients with potential circulatory compromise.

The HyperView product produces similar data and images as HyperMed’s prior OxyVu-1 product which has been in service in the United States for many years. In comparison to OxyVu-1, the new HyperView product is smaller, faster and more portable. There are many research publications establishing the OxyVu-1 product effectiveness in a number of key applications involving tissue oximetry. Such applications involve, among others, wound care and associated vascular complications of diabetes and peripheral vascular disease.

Aristidis Veves, M.D., DSc, Harvard Medical School professor of surgery and research director of the Microcirculation Lab at Beth Israel Deaconess Medical Center commented, “The HyperView is a new and innovative product that can provide clinicians a better understanding of surface perfusion and localized oxygen delivery in patients with potential circulatory compromise, which is important for a number of applications including limb ischemia, wound healing and reconstructive surgery.” Veves is chairman of HyperMed Imaging’s Scientific Advisory Board.

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