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.

For more information: www.hypermed.com


Related Content

News | Point of Care Testing

August 5, 2019 — A West Virginia-based rural medical outreach event showcased the use of point-of-care technology in an ...

Home August 05, 2019
Home
News | Point of Care Testing

July 26, 2017 — Siemens Healthineers has entered into a definitive agreement to acquire Epocal Inc., a subsidiary of ...

Home July 26, 2017
Home
News | Point of Care Testing | Dave Fornell

July 17, 2017 — Despite issues with point-of-care INR testing company Alere Inc., Abbott announced this week it is once ...

Home July 17, 2017
Home
Feature | Point of Care Testing | Nicholas C. Vanderslice, Ph.D., and Arnol S. Rios

Point-of-care (POC) coagulation analyzers that measure prothrombin time/international normalized ratio (PT/INR) on ...

Home May 05, 2017
Home
Feature | Point of Care Testing | Ravi Chawat

Point of care testing devices are gaining widespread approval for prompt medical diagnoses, especially in cardiology and ...

Home December 30, 2016
Home
Feature | Point of Care Testing

December 7, 2016 — Abbott has filed a complaint to terminate its proposed acquisition of Alere based on the substantial ...

Home December 07, 2016
Home
Technology | Point of Care Testing

November 10, 2016 — Siemens Healthineers announced U.S. Food and Drug Administration (FDA) 510(k) clearance for a hand ...

Home November 10, 2016
Home
News | Point of Care Testing

February 3, 2016 — Abbott and Alere Inc. announced a definitive agreement for Abbott to acquire Alere. Under the terms ...

Home February 03, 2016
Home
News | Point of Care Testing

December 22, 2015 — Trinity Biotech plc announced submission of its Meritas Point of Care Analyzer and Meritas cardiac ...

Home December 22, 2015
Home
News | Point of Care Testing

October 13, 2015 — The Lancet published results online that show Abbott’s ARCHITECT STAT High Sensitive Troponin-I ...

Home October 13, 2015
Home
Subscribe Now