Devices & Diagnostics

EndoChoice wins FDA 510(k) clearance for gastroscope with wider field of view

EndoChoice, an Atlanta, Ga.-based healthcare startup, announced it’s received 510(k) clearance for its Fuse Gastroscope. It’s not the first positive FDA device approvals news the company has gotten this year either: It received FDA clearance for its Fuse Colonoscope in May. The gastroscope expands the physician’s range of view from about 140 degrees to 245 […]

EndoChoice, an Atlanta, Ga.-based healthcare startup, announced it’s received 510(k) clearance for its Fuse Gastroscope. It’s not the first positive FDA device approvals news the company has gotten this year either: It received FDA clearance for its Fuse Colonoscope in May. The gastroscope expands the physician’s range of view from about 140 degrees to 245 degrees, in an effort to help “facilitate diagnoses” in the upper gastrointestinal tract, according to a company statement.

Adenomas, often missed by traditional (forward-view only) endoscopy, should be easier to find with a wider field of view, according to the company’s research. Inspired by origami (go figure), the EndoChoice engineering team has found a way to put multiple small cameras on the tip of an endoscope (instead of just one). It’s part of what they call Full Spectrum Endoscopy. (Check out how the endoscopes work in the video above, which emphasizes the colonoscope.)

From the press release:

Because of the folds that occur naturally in the colon and stomach anatomy, problem areas can easily go undetected when using traditional endoscopes. The Fuse system allows GI doctors to see into and behind those folds. The images of the anatomy are displayed on high-definition screens specially arranged to give the doctor a full spectrum view.

It uses LED-lighting and works with the Fuse Panel, which is EMR-ready, according to the website.

The company “has been recognized for four consecutive years as one of the fastest growing companies in the U.S. by Inc. Magazine,” according to the press release.

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