HyperMed receives FDA clearance for new medical imaging device

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The U.S. Food and Drug Administration (FDA) has given clearance to HyperMed Imaging’s new medical imaging device, HyperView.

The handheld diagnostic imaging device allows physicians and healthcare professionals to noninvasively measure tissue oxygenation that reports approximate levels of oxygen saturation, oxyhemoglobin level and deoxyhemoglobin levels in superficial tissue.

The scanned areas provide 2D color-coded images of tissue oxygenation for patients with potential circulatory compromise.

“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,” said HyperMed’s President and CEO Mark Darty in a press release.

This product is similar to HyperMed’s OxyVu-1, but is smaller, faster and more portable.

“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,” said Aristidis Veves, MD, DSc, Harvard Medical School Professor of Surgery and Research Director of the Microcirculation Lab at Beth Israel Deaconess Medical Center in a statement.