Check-Cap receives conditional approval of IDE application to initiate C-Scan pilot study: 4 notes

The FDA granted conditional approval of medical diagnostic company Check-Cap's investigational device exemption application to begin a pilot study of the company's C-Scan system.

Here are four things to know:

1. The conditional approval of the IDE requires Check-Cap to provide additional information to the FDA. The company can begin enrolling patients in the study immediately upon approval by the study site's institutional review board.

2. Designed to detect precancerous polyps, C-Scan is a capsule-based screening method to detect colorectal cancer.

3. The system 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 patient's colon.

4. C-Scan is designed to be noninvasive and requires no preparation or sedation.

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