Saneso Novel 360° Colonoscope Receives FDA Clearance
Saneso Inc., a leading US developer of next gen endoscope systems announces today the US Food and Drug Administration (FDA) has granted 510(k) clearance of its novel integrated 360° field of view colonoscope.
“We are pleased to extend the world’s first and only 360° colonoscope to all physicians, hospitals, and ASCs who will benefit from this expansive and state of the art technology,” said Saneso’s Director of Public and Government Affairs, Mr. Bobby C. Bleir. “Traditional colonoscopes are limited by a 140° to 170° field of view and can’t see around the folds and turns of the GI Tract. This can cause them to miss 25-40% of polyps. Saneso’s 360° Multidirectional Integrated Vision colonoscope has five cameras and combines all images into a consolidated 360° view of the colon and that kind of technology can save lives.”
To support its application, Saneso commissioned an independent study published in the American College of Gastroenterology in which 324 endoscopists from the US used Saneso’s colonoscope. The study compared traditional single camera colonoscopes to Saneso 360° colonoscope using 20 anatomic colon models. The study showed 100% of the endoscopists (P < 0.0001) discovered more polyps with Saneso versus traditional single camera colonoscopes. “And it further showed that the discovery of the additional polyps was not predicated on physician’s experience level or practice environment,” added Brandy Crawford, VP of Clinical Affairs. “Our endoscopes are comfortably familiar in operation to traditional endoscopes.”
In addition to its revolutionary 360° field of view, Saneso endoscopes have innovative tissue wash and multi lens wash systems: “Select Band Imaging” which enables examination of the GI tract in a narrow spectrum, and “Dual Band Imaging” which enables examination of the GI tract simultaneously under two spectra.
Saneso is a leading medical technology company headquartered in Pittsburgh, PA dedicated to improving patient outcomes and bettering patient health through the development of next generation endoscope systems. Our groundbreaking five-camera endoscope platform provides an unprecedented 360° integrated view of the gastrointestinal tract.
See Full Press Release at the Source: Saneso Novel 360° Colonoscope Receives FDA Clearance
Press Release by: Saneso Inc.
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