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SonoScape Receives FDA 510(k) Clearance for HD-550 Endoscopy System

SonoScape HD-550 Endoscopy System

On April 15th, SonoScape today announced that the U.S. Food and Drug Administration (FDA) has approved its flagship video endoscopy system HD-550 for gastrointestinal diagnosis, setting up a major milestone on SonoScape’s Endoscopic product roadmap.

Paired with a 4-LED light source, which supports 1080P high definition, the HD-550 endoscopy system enables multi-spectrum and multi-mode. Adding to the high-performing white-light mode, its chromoendoscopy SFI (Spectral Focused Imaging) and VIST (Versatile Intelligent Staining Technology) light modes enhance vascular and mucosal color contrast. As a result, more details in the GI tract can be revealed, which may help doctors in detection, demarcation, and characterization of the lesions. Included in the clearance are the 550 series videoscopes, whose maneuverability has been endorsed by top endoscopists around the world.

The HD-550 endoscopy system has been available outside of the USA since 2019. By 2021, HD550’s top-of-the-line features and quality combined with its versatility saw it installed in close to 40 countries around the world and has made SonoScape the third best-selling brand in China.

“We have grown into a trusted name in the global endoscopy industry, we are now ready to extend our offerings to the USA healthcare providers.” Steven He, Sales Director of SonoScape Endoscopy commented, “This FDA clearance opens up opportunities in one of the world’s biggest endoscopy markets, indeed is a powerful boost of our brand recognition, and a tremendously important phase of business development in SonoScape’s 20 years’ history”.

About SonoScape

Founded in 2002 in Shenzhen China, SonoScape has committed itself to “Caring for Life through Innovation” by providing ultrasound and endoscopy solutions. With seamless support, SonoScape provides worldwide sales and service in more than 130 countries, benefiting local hospitals and doctors with comprehensive imaging diagnostic evidence and technical support. Investing 20% of total revenue into R&D annually, SonoScape establishes seven R&D centers in Shenzhen, Shanghai, Harbin, Wuhan, Tokyo, Seattle, and Silicon Valley, with more advanced products to be introduced into the pipeline.

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SOURCE SonoScape Medical Corporation