The US Food and Drug Administration (FDA) has granted 510(k) clearance for the commercialisation of Motus GI’s Pure-Vu EVS System.
The new device is designed to enhance navigation capabilities in tortuous anatomy and improve the speed of set-up.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
It offers enhanced cleansing capabilities and improved navigation to support expanded clinical utilisation.
During a colonoscopy, the Pure-Vu EVS System helps physicians quickly handle the challenges of a poorly prepared colon.
It is intended to provide significant usability advancements, such as expanded cleansing capacity, on-demand bedside loading, a smaller workstation footprint, and enhanced physician navigation and control.
Motus GI CEO Tim Moran said: “The development and innovation we’ve implemented in Pure-Vu EVS is the result of listening to valuable feedback from leading physicians and clinical staff that have utilised our Pure-Vu platform.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalData“This FDA clearance of Pure-Vu EVS is expected to allow a greater number of physicians and hospitals to bring this important technology to their patients.
“Additionally, the new EVS oversleeve is able to be loaded on a ‘dirty’ scope in the procedure room, an important new capability that will allow broader utilisation of Pure-Vu to help physicians complete difficult cases and better visualise the colon mucosa.”
The company stated that its Pure-Vu platform fits on standard colonoscopes to enable intraprocedural cleansing of the colon.
It also helps to preserve the established procedural workflow by evacuating debris and irrigating the colon to provide a better examination.
Motus GI plans to commercially launch the Pure-Vu EVS System in the first quarter of the year.
