US-based medical device company EndoChoice has obtained marketing licence from Health Canada for its Fuse Full Spectrum Endoscopy system.
According to EndoChoice, the Health Canada licence means that its Fuse system will be the first endoscopy system available with expanded viewing capabilities to reach Canadian patients.
Featuring colonoscopes and gastroscopes with multiple imagers, the Fuse Full Spectrum Endoscopy system allows doctors to see more of the gastrointestinal tract for diagnosis and treatment.
EndoChoice’s Fuse system is a proprietary arrangement of three small cameras at the tip of a flexible GI endoscope. By using three cameras, the Fuse system allows doctors to see nearly twice as much surface area as they can with traditional endoscopes that only use one camera.
While traditional endoscopes offer a limited field of view (no more than 170° for colonoscope), the Fuse system provides a significantly expanded field of view (330° for colonoscope).
The Fuse system identified 70% more polyps than traditional colonoscopies in clinical studies. Being able to see more anatomy may allow doctors to find more pre-cancerous polyps.
EndoChoice founder and CEO Mark Gilreath said: “While 2013 has been an exciting year for our company, the introduction of Fuse into Canada and other markets will enable us to make 2014 even more dynamic as we bring this game-changing technology to more clinician.”
EndoChoice previously obtained 510(k) clearance from the US Food and Drug Administration for the Fuse system.
On 9 January, EndoChoice launched its investigator-initiated study programme (IIS) to further build clinical evidence for the Fuse endoscopy system.
The Fuse IIS programme will provide research grants to interested researchers to support independent, investigator-initiated research that is scientifically compelling and consistent with advancing the understanding of the clinical significance of the Fuse technology.
Image: EndoChoice receives Health Canada licence for Fuse endoscopy system. Photo: courtesy of PRnewswire/EndoChoice.