The Israel-based company’s C-Scan system is designed as an alternative to standard colon cancer screening methods. The system uses an ingestible, ultra-low dose X-ray capsule and a wireless tracking system to return structural information on the lumen of the colon to create 2D and 3D maps.
Physicians can use maps created by the system to identify pre-cancerous polyps and other abnormalities, Check-Cap said.
“Achieving CE Mark approval is a significant accomplishment and an important milestone for our Company. This is a key validation of C-Scan and its potential as a convenient and comfortable option for identifying polyps in the colon. We look forward to continued progress on our initiatives and remain on target to commence our European post-approval and U.S. pilot trials, each in the 1H2018, as we define marketing and commercialization pathways throughout 2018,” CEO Bill Densel said in a press release.
The company originally filed for CE-Mark approval of its C-Scan ingestible capsule last September.