FDA Approves CMR Surgical's Robotic Device for Gallbladder Removal in U.S. 🇺🇸🤖

UK-based medical device company CMR Surgical has received clearance from the U.S. Food and Drug Administration (FDA) for the upgraded version of its Versius Surgical System to assist in gallbladder removal procedures. The robotic device, which is portable, is approved for patients aged 22 and older who qualify for minimally invasive surgery 🏥🔧. This marks a major milestone for CMR Surgical, which aims to fill a market gap with its innovative system. While the company has not disclosed details about commercialization or pricing for the U.S. market, it expects the cost to be "favorable" 💲. Initially, CMR plans to partner with a few U.S. hospitals before gradually expanding its reach nationwide 🏨. The Versius device was cleared through the FDA's De Novo application process, a pathway reserved for novel medical devices that lack a legally marketed equivalent in the U.S. Prior to this, the system had already secured its CE mark in Europe in 2019 🇪🇺.