HyperMed Imaging's HyperView System Approved in Europe

April 3, 2018—HyperMed Imaging, Inc. announced that it has received European CE Mark approval for its HyperView medical imaging system. With the approval, HyperView, which is currently distributed in the United States, will also be distributed in Europe beginning this year.

According to the company, the HyperView system is a handheld, battery-operated, noninvasive, and portable diagnostic imaging device that is used to quickly assess tissue oxygenation without contacting the patient. The system captures a diagnostic image containing data for oxyhemoglobin levels, deoxyhemoglobin levels, and oxygen saturation in superficial tissue.

The HyperView system may assist clinicians in determining if a wound has adequate perfusion to heal. Also, clinicians can assess if a vascular intervention or additional therapy is needed to improve perfusion.

HyperMed's technology uses visible hyperspectral imaging for assessment of tissue oximetry in the superficial capillary bed. The company explained that as opposed to near-infrared light, visible hyperspectral imaging avoids mixing data from subcutaneous arteries and veins with that from the superficial capillary bed where oximetry data are different. In published clinical research, HyperMed’s technology demonstrated consistent readings on which perfusion adequacy levels can be assessed, stated the company.

Bauer Sumpio, MD, commented in the company's announcement, “The HyperView product provides significant benefit in determining regional foot perfusion adequacy in vascular compromised patients. It is fast, easy, and provides reliable diagnostics in comparison to existing standard of care devices. Endovascular surgery, wound care, and reconstructive surgery are all important areas which could benefit from the use of the product. Its use as a screening tool prior to vascular interventions or various wound healing therapies can document the need for the procedure and its use postprocedure can document the success and effectiveness of such procedures.” Dr. Sumpio is Professor of Surgery, Radiology, and Medicine at Yale University School of Medicine in New Haven, Connecticut.