The US Food and Drug Administration has granted Investigational Device Exemption (IDE) status to the C-Scan colorectal cancer screening device from Israel's Check-Cap Ltd, the company announced Monday.
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C-Scan is intended for candidates who are at average risk for colorectal cancer but who are poor candidates for colonoscopy or decline to undergo a colonoscopy, or who had an incomplete optical colonoscopy. The device uses an ultra-low dose X-ray capsule, an integrated positioning, control and recording system, as well as proprietary software to generate a 3D map of the inner lining of the colon as it travels along the gastrointestinal tract. Check-Cap notes that C-Scan is non-invasive and requires no sedation.
IDE approval allows Check-Cap to begin a study of C-Scan in the US to evaluate the safety and performance of C-Scan as well as subject compliance with C-Scan.
Check-Cap CEO Alex Ovadia said, "We will be continuing to optimize C-Scan's performance and patient experience through additional clinical data collection at Israeli sites. To this end, we are gearing up to initiate a study in Israel at more than 10 clinical sites to enroll up to 250 average risk patients."
