Colon capsule developer Check-Cap has signed an agreement for GE Healthcare to manufacture its C-Scan low-dose ingestible x-ray capsule for U.S. clinical trials.
The C-Scan system is currently manufactured in Israel, where Check-Cap is located. GE's manufacturing line will be responsible for assembling the x-ray source, final calibration, testing, packing, and distribution, Check-Cap CEO Alex Ovadia told AuntMinnie.com in an email.
Check-Cap is conducting a pilot clinical trial in the U.S. to evaluate the safety, usability, and subject compliance of the C-Scan system at the New York University School of Medicine and the Mayo Clinic in Rochester, MN.
Assuming the pilot trial results are promising, Check-Cap plans to file with the U.S. Food and Drug Administration (FDA) for the approval of a pivotal clinical trial, which could begin next year. The C-Scan system has already received the CE Mark for marketing in Europe and approval from the Israeli Ministry of Health for marketing in Israel.