HyperMed Imaging, Inc. announced it has received clearance from the U.S. Food and Drug Administration (FDA) for the company’s new medical imaging device called HyperViewTM.
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 OxyVuTM-1 product which has been in service in the US 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.
“The new HyperView product represents a significant advancement in non-invasive assessment of superficial tissue oxygenation,” according to Mark Darty, President of HyperMed.
“We began years ago by first meeting with clinicians to understand their working environment and determine user requirements. The need for portability, ease of use and speed of imaging required a full custom design for the HyperView product. Our team’s effort has long been energized by a belief that the HyperView product holds great potential to positively impact the lives of millions of patients. With this new FDA clearance we are now pleased to be able to offer clinicians and patients in the US this exciting next generation imaging device.