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WASHINGTON — UK-based medical device maker CMR Surgical said on Tuesday that the U.S. Food and Drug Administration has cleared the upgraded version of its surgical robot to be used in gallbladder removal procedures.
The portable device, called Versius Surgical System, was cleared for use in patients aged 22 years and older who are eligible for minimally invasive surgery, the company said.
CMR Surgical did not disclose its commercialization plans and pricing details for the U.S., but said it expects the total cost to be "favorable."
"This is a significant opportunity and CMR is confident that by addressing a gap in the market Versius can be a successful product in the U.S.," the company said.
CMR said it plans to initially partner with a select number of U.S. hospitals before expanding nationwide.
The device has been cleared through the FDA's De Novo application process, which provides a marketing pathway to classify novel medical devices that have no legally marketed equivalent or predicate device.
The device had also secured the European Union's CE mark in 2019.
