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

With the advent and optimization of nuclear scintigraphy protocols using bone-avid radiotracers, cardiac amyloidosis caused by transthyretin protein (ATTR) can now be diagnosed noninvasively without a costly tissue biopsy. The radiotracer 99mTc-pyrophosphate (99mTc-PYP) binds to deposited ATTR amyloid fibrils in the myocardium and can be visualized using planar and SPECT imaging. Amyloidosis Patient Registry  #Amyloidosis

With the advent and optimization of nuclear scintigraphy protocols using bone-avid radiotracers, cardiac amyloidosis caused by transthyretin protein (ATTR) can now be diagnosed noninvasively without a tissue biopsy. The radiotracer 99mTc-pyrophosphate (99mTc-PYP) binds to deposited ATTR amyloid fibrils in the myocardium and can be visualized using planar and SPECT imaging. This is Figure 2, showing how SPECT imaging allows the reader to distinguish between blood pool activity (ventricular cavity, etc) and myocardial activity and identify regional myocardial differences in radiotracer uptake.

News | Cardiac Diagnostics | March 05, 2020
March 5, 2020 — More than 300 patients have joined the Amyloidosis Patient Registry and it is now available to the en
heart disease image
News | Cardiac Diagnostics | December 18, 2019
December 18, 2019 — In their latest report, “...
FDA Warns Troponin Tests Impacted by Biotin Dietary Supplement
Feature | Cardiac Diagnostics | November 05, 2019 | Dave Fornell, Editor
November 5, 2019 — The U.S.
Videos | Cardiac Diagnostics | October 29, 2019
Doctor Clyde Yancy was a keynote speaker and said doctors need to check their assumptions about patients at the door...
79-year-old Tony Marovic had a right carotid endarterectomy shortly after discovering a 95 percent blockage of his carotid artery at a health and wellness screening event

79-year-old Tony Marovic had a right carotid endarterectomy shortly after discovering a 95 percent blockage of his carotid artery at a health and wellness screening event. Image courtesy of University Hospitals.

News | Cardiac Diagnostics | October 16, 2019
Health and wellness screenings are more than just nice events for the community – they can save lives. A Mentor, Ohio,...
Pesticide Exposure May Increase Heart Disease and Stroke Risk

Image courtesy of zefe wu from Pixabay

News | Cardiac Diagnostics | October 15, 2019
On-the-job exposure to high levels of pesticides raised the risk of heart disease and stroke in a generally healthy...
World Heart Federation Launches Global Roadmap on Cardiovascular Disease Prevention Among Diabetics
News | Cardiac Diagnostics | September 04, 2019
At the European Society of Cardiology (ESC) Congress 2019 together with the World Congress of Cardiology, the World...
Insomnia Tied to Higher Risk of Heart Disease and Stroke

Image courtesy of the American Heart Association

News | Cardiac Diagnostics | August 19, 2019
People suffering from insomnia may have an increased risk of coronary artery disease, heart failure and stroke,...