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.
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.
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“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.