HyperMed Imaging, Inc. Receives FDA Clearance for Its New HyperView™ Product
January 10, 2017 / Memphis, TN
HyperMed Imaging, Inc. announced today 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 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.
HyperMed’s President and CEO Mark Darty stated, “The new HyperView product represents a significant advancement in non-invasive assessment of superficial tissue oxygenation. 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.”
Dr. Aristidis Veves, 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.” Dr. Veves is Chairman of HyperMed Imaging’s Scientific Advisory Board.
HyperMed Imaging, Inc. is a privately owned medical device company and the market leader in hyperspectral medical imaging. HyperMed pioneered the use of its novel version of hyperspectral imaging for assessment of superficial tissue oximetry with its OxyVu-1 device, first cleared by the FDA in 2006. HyperMed currently has over 30 issued patents and more than 40 additional patents pending worldwide on its hyperspectral medical imaging technology and associated products.
For more information, visit: https://www.hypermed.com/
HyperMed Imaging, Inc. is not offering for sale any medical device at this time.
HyperMed and HyperView are trademarks of HyperMed Imaging, Inc.
Contact:
Max Mortensen, PhD
VP Regulatory Compliance and Quality Assurance
1-844-HYPRMED / 1-844-497-7633
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