EndoChoice wins FDA 510(k) for Lumos imaging software

EndoChoice said today it won FDA 510(k) clearance for its Lumos imaging software system, part of the company’s 3 Fuse Full Spectrum Endoscopy system, and launched the system in the U.S.

The Lumos system is designed with adaptive matrix imaging to analyze and selectively enhance vascularity, surface texture and color of abnormal tissue to return more detailed information for detecting abnormalities during GI procedures, the Alpharetta, Ga.-based company said.

“Other image processing technologies alter the image, which can be distracting. With Lumos, only anatomy that has certain textures, vascularity or abnormal anatomy is enhanced, allowing me to keep my focus on potentially diseased tissue,” Dr. Peter Siersema of The Netherlands’ Radboud University Medical Center said in a press release.

EndoChoice said it launched the Lumos system in “key international markets” in Febraury.

“We are excited to introduce new innovations that continue to deliver on the Fuse brand promise of seeing more. We expect that Lumos with Adaptive Matrix Imaging will become an indispensable tool for the GI endoscopist,” CEO Mark Gilreath said in prepared remarks.

In May, EndoChoice said it won FDA 510(k) clearance for its Orca sterile, single-use air, water and suction valves designed for Olympus 160, 180 and 190 flexible endoscopes, and announced the launch of its 3rd-gen Fuse endoscopy system and RescueNet retrieval device.

With the clearance for the Orca valves, as well as previous regulatory wins, EndoChoice will begin sales and distribution in the U.S., European Union and other select markets, EndoChoice said.

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