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

Biotronik Studies Demonstrate Efficacy of Minimizing Metal Burden in SFA Therapy
News | Stents Bare Metal| September 22, 2017
Physicians demonstrated that reducing metal burden in superficial femoral artery (SFA) therapy could effectively reduce...
Tryton Side Branch Stent Recognized With Premier Technology Breakthrough Award
News | Stents Bifurcation| September 21, 2017
September 21, 2017 — Cardinal Health and Tryton Medical Inc.
Lesion Preparation Via Atherectomy Enhances Paclitaxel Distribution in Calcified Peripheral Arteries
News | Peripheral Artery Disease (PAD)| September 20, 2017
September 20, 2017 — Not-for-profit preclinical research institute CBSET announced that its scientists have published
DISRUPT BTK Study Shows Positive Results With Lithoplasty in Calcified Lesions Below the Knee
News | Peripheral Artery Disease (PAD)| September 20, 2017
Shockwave Medical reported positive results from the DISRUPT BTK Study, which were presented at the annual...
Corindus Announces First Patient Enrolled in PRECISION GRX Registry
News | Robotic Systems| September 18, 2017
September 18, 2017 — Corindus Vascular Robotics Inc.
Two-Year ILLUMENATE Trial Data Demonstrate Efficacy of Stellarex Drug-Coated Balloon
News | Drug-Eluting Balloons| September 18, 2017
Philips announced the two-year results from the ILLUMENATE European randomized clinical trial (EU RCT) demonstrating...
Sentinel Cerebral Protection System Significantly Reduces Stroke and Mortality in TAVR
News | Embolic Protection Devices| September 18, 2017
September 18, 2017 – Claret Medical announced publication of a new study in the...
Fysicon Receives FDA Approval for QMAPP Hemodynamic Monitoring System
Technology | Hemodynamic Monitoring Systems| September 18, 2017
Fysicon announced that it has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its...
NIAID Scientists Illuminate Mechanism of Increased Cardiovascular Risks With HIV
News | Cardiac Diagnostics| September 14, 2017
September 14, 2017 — Scientists at the National Institutes of Health have expanded the understanding of how chronic i
Marijuana Associated With Three-Fold Risk of Death From Hypertension
News | Hypertension| September 14, 2017
Marijuana use is associated with a three-fold risk of death from hypertension, according to research published recently...
Overlay Init