Motus GI Holdings has secured approval from the Israeli Ministry of Health, Medical Device Division (AMAR) for initiating commercial sales of its Pure-Vu EVS System in the country.
To enhance visualisation during colonoscopy without disrupting the established procedural workflow and techniques, the Pure-Vu EVS System can be integrated with both standard and slim colonoscopes.
It is a single-use oversleeve intended to deliver better-quality exams by irrigating and evacuating debris.
The system assists physicians in managing urgent or complex colonoscopies by quickly and safely offering a clear view of the colon wall.
It is powered by three proprietary technologies for safe intraprocedural cleansing of the colon walls.
The technologies include Pulsed Vortex for irrigation, Smart Sense for suction and Smooth Glide for navigation.
The US Food and Drug Administration has already approved the Pure-Vu EVS for aiding in the cleansing of a poorly prepared gastrointestinal tract during colonoscopy.
Motus GI CEO Mark Pomeranz said: “We are pleased to secure regulatory clearance for the Pure-Vu EVS System in Israel, which is considered an advanced medical system globally and one of the largest markets in this region.
“Leading healthcare systems in a number of regions in the US and the Veterans Health Administration are currently utilising the Pure-Vu EVS System.
“Gaining regulatory approval in various regions of the world supports our strategy to enable strategic partnerships with medical device companies on a global basis.”
With subsidiaries in Israel and the US, Motus GI offers endoscopy solutions for the diagnosis and management of gastrointestinal conditions.