EndoChoice got the FDA’s green light for the Fuse endoscopy system, which the company says features numerous improvements over traditional endoscopy technology and will help docs catch more tumors.
The Alpharetta, Ga.-based colonoscopy device maker said its clinical trials demonstrated that Fuse only has a tumor "miss-rate" of 8%, compared with 42% with a traditional device.
Fuse is equipped with 3 small cameras that provide a 330 degree view (nearly double the range of typical colonoscopy cameras), and the device fits the images together to create a panoramic view of the GI tract illuminated small LED lights, according to the company.
"Since we announced the expansion of our company in January, our teams in Germany and the U.S. have been working diligently to develop and launch the revolutionary Fuse endoscopy system," CEO Mark Gilreath said in a prepared statement. "This FDA milestone brings us yet another step closer to our mission of serving the GI professionals so they can give the best possible care to their patients."
EndoChoice started 2013 with a bang after announcing a merger with Peer Medical, a $43 million funding round led by Sequoia Capital and the acquisition of German endoscope maker RMS Endoskopie-Technik.