HyperMed Imaging, Inc. Receives UL Certification for New Product
May 1, 2016 / Memphis, TN
HyperMed Imaging, Inc. has received Underwriters Laboratories (UL) Certification for its new medical imaging device. HyperMed worked with UL to test and evaluate the company’s new medical device for compliance to domestic and international safety standards.
HyperMed’s CEO Mark Darty commented, “This UL certification and our recent completion of clinical validation studies have allowed our company to submit its 510(k) request for clearance to the US Food and Drug Administration. This represents a major milestone toward the goal of commercializing our next generation tissue oximetry product.”
HyperMed Imaging, Inc. is a privately owned medical device company and the market leader in hyperspectral medical imaging. HyperMed pioneered the use of its novel version of hyperspectral imaging for assessment of surface tissue oximetry with its OxyVu™-1 device, first cleared by the FDA in 2006. HyperMed’s new generation medical imaging device is currently pending FDA clearance. HyperMed is not selling any medical devices at this time.