Smart Medical Systems’ G-Eye Colonoscope Gets FDA 510(k) Clearance

Smart Medical Systems has received an additional FDA 510(k) clearance for its G-Eye colonoscope, which includes a proprietary balloon at its distal end.

With the additional FDA clearance, G-Eye is now available for use in the U.S. market on the commonly used colonoscope models of all three leading endoscopy brands — Olympus, Fujifilm and Pentax Medical.

Withdrawal of the G-Eye colonoscope with the balloon moderately inflated during colonoscopy assists in controlling the scope's field of view and positioning. This has been shown to increase the adenoma detection rate by 28 percent, the company said.