EndoQuest Receives FDA Approval to Initiate Final Stage of PARADIGM Trial [Yahoo! Finance]
HCA Healthcare, Inc. (HCA)
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Source: Yahoo! Finance
HOUSTON, January 15, 2026 BUSINESS WIRE )--EndoQuest Robotics, Inc., a pioneering leader in endoluminal robotic surgical technology, today announced that the U.S. Food and Drug Administration (FDA) has approved initiation of the next and final stage of its pivotal multicenter trial, the PARADIGM Trial (Prospective Assessment of a Robotic Assisted Device in Gastrointestinal Medicine) . The PARADIGM Trial is an Investigational Device Exemption (IDE) study evaluating EndoQuest's Endoluminal Surgical (ELS) System for use in endoscopic submucosal dissection (ESD) ( Clinicaltrials.gov The FDA's decision follows submission of a report on the safety results of the ELS System for the first set of subjects. This approval allows for completion of enrollment in advance of EndoQuest's planned De Novo Classification Request for authorization to market the ELS System in the U.S. This first set of procedures was completed by world-renowned pioneers in endoluminal surgery, including gastroenterol
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