Motus GI Gets FDA’s 510(k) Clearance for Its Pure-Vu Colonoscopy System
Motus GI Holdings has received 510(k) clearance from the FDA for its Pure-Vu EVS colonoscopy system, used to irrigate the colon and remove debris prior to an examination.
The EVS (endoscopic visualization system) features enhancements over the currently marketed device, including better navigation and control, on-demand bedside loading, expanded cleansing capacity, and a smaller workstation footprint.
The new device features an oversleeve that can be placed over a previously used scope in the procedure room, an important new capability that will “help physicians complete difficult cases and better visualize the colon mucosa,” the company said.
Motus GI said it plans to launch the Pure-Vu EVS in the first quarter of 2022.