GI medical devices developer Given Imaging has submitted an application to US Food and Drug Administration (FDA) seeking approval to use its non-invasive imaging tool for visualization of the lower gastrointestinal tract.
The PillCam Colon 2 capsule endoscopy system, which features two miniature color video cameras, a battery and an LED light source, measures 11.6mm X 31.5mm.
When ingested by a patient, the capsule transmits up to 35 frames per second for around ten hours, which are transferred to a computer and compiled as video data for analysis by a physician.
Complementary to colonoscopy, the PillCam COLON 2 capsule is designed for patients who are at a higher risk for complications from colonoscopy as well as for patients who received an incomplete optical colonoscopy.
The diagnostic use of imaging tool will minimize potential adverse events and reduce the risks associated with radiation-based alternative procedures such as CT colonography or double-contrast barium enema, claims the company.
The company, which has submitted its PillCam COLON 2 application based on guidance provided by the FDA, believes that the direct de novo pathway may expedite the regulatory approval process by a few months.
Given Imaging president and CEO Homi Shamir said, "Filing for FDA clearance is another important milestone for Given Imaging in advancing our efforts to commercialize PillCam COLON 2."