SonoScape video endoscopy system receives FDA 510(k) clearance
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SonoScape Medical Corp. announced that the FDA has approved its video endoscopy system HD-550 for gastrointestinal diagnosis.
“It is great to see more companies entering the U.S. endoscopy market,” Klaus Mergener, MD, of the University of Washington School of Medicine, told Healio. “As physicians, we are interested in continued innovation and improvements in endoscopy, and a larger number of competitor companies should help drive such advances and provide endoscopists with a variety of instrument choices.”
According to a company press release, the HD-550 endoscopy system uses chromoendoscopy spectral-focused imaging and versatile intelligent staining technology light modes to enhance vascular and mucosal color contrast, improving detection and characterization of lesions in the GI tract. The endoscopy system has been available outside the United States since 2019 and has been installed in approximately 40 countries worldwide.
“We have grown into a trusted name in the global endoscopy industry, and we are now ready to extend our offerings to U.S. health care providers,” Steven He, sales director of SonoScape Endoscopy, said in the release. “This FDA clearance opens up opportunities in one of the world's biggest endoscopy markets, is a powerful boost of our brand recognition and a tremendously important phase of business development in SonoScape’s 20-year history.”
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