SMART Medical Systems’ Colonoscope Gets FDA Clearance

SMART Medical Systems has received 510(k) clearance from the FDA for its G-EYE colonoscope, a device that uses an integrated balloon to improve detection capabilities.

The device is a standard colonoscope with the company’s G-EYE balloon attached to its bending section, which centralizes the image of the colon, and reduces slippage to help control the field of view and positioning.

Clinical studies showed that, when compared to standard colonoscopy, the G-EYE colonoscope showed a substantial increase in detecting cancerous polyps, the company said.