FDA Panel: “CTC is Safe & Effective”

More good news for proponents of CT colonography as a screening tool! In a joint meeting with the Food and Drug Administration (FDA), the Gastroenterology- Urology Devices Panel and the Radiological Devices Panel of the Medical Devices Advisory Committee, the use of CT colonography (CTC) as a screening tool for routine colorectal cancer screening was deemed safe and effective.

A joint committee representing experts in radiology, oncology, gastroenterology and surgery addressed the safety factors associated with radiation exposure, morbidity from incidental clinical findings and potential benefits of CTC, including the test’s performance characteristics and the potential impact on screening utilization.

I was extremely pleased to present on behalf of the American College of Radiology on the extremely low radiation dose and perforation risk associated with CTC, its general efficacy as a screening tool and research data from a clinical trial experience with a Medicare population.

The FDA panel also heard presentations from representatives of the Society of Abdominal Radiology, the Society of Computed Body Tomography and Magnetic Resonance and the American Association of Physicists in Medicine.

Next, the committee will share their deliberations with the Center for Devices and Radiological Health as they continue to oversee approval and oversight of imaging devices.