Home » Pure-Vu System Earns CE Mark
Pure-Vu System Earns CE Mark
Devices Submissions and Approvals
Motus GI secured a CE mark in the European Union for its Pure-Vu system.
The device fits over most standard colonoscopes and allows physicians to clean poorly-prepped colons to improve clinical outcomes. It has already secured 510(k) approval from the FDA and is being piloted in the United States.
The company received CE mark approval based on positive clinical study results it re ported last November and it plans to continue post-approval trials over the next year.