Given Imaging seeks FDA approval for GI tract capsule

Given Imaging has filed an FDA application seeking regulatory clearance to market its PillCam Colon 2 capsule for visualization of the lower gastrointestinal (GI) tract.

PillCam Colon 2 is complementary to colonoscopy, and provides an alternative method of lower GI tract imaging for patients who are unable to undergo colonoscopy, according to the Yoqneam, Israel-based company.

Given submitted the FDA application through a direct de novo pathway, which the company said should expedite the approval process under new guidelines.