Endochoice (Alpharetta, GA) received FDA 510(k) clearance for the Fuse 1G Gastroscope that features a 245 degree field of view. The companion product, the Fuse 1C Colonoscope with a 330 degree field of view, was FDA cleared in May of this year. The Fuse 1G Gastroscope’s wider field of view is a major advancement in gastroscopy technology since traditional gastroscopes have a field of view of approximately 150 degrees and are essentially only forward looking.
The Fuse system shows images on three screens instead of one, thereby allowing visualization of more of the GI tract along, helping to cover difficult to image anatomic structures. Optimal imaging is enabled through the use of multiple cameras and built-in LED lighting around the tip to provide illumination. The system uses a FuseBox control unit with the FusePanel image management system to interface with EMRs for tracking of patients, physician IDs and procedures performed. It also enables saving of every image for viewing or printing at a later date. Images can be captured remotely or can be exported in PDF format to be used on other EMR systems.
Flashback: Endochoice Fuse Receives FDA Clearance; Reduces Colonoscopy Miss Rate…
Product page: Fuse Full Spectrum Endoscopy…
Press release: FDA Grants 510(k) Clearance for Innovative Fuse Gastroscope from EndoChoice…