US FDA Grants Investigational Device Exemption (IDE) to EndoQuest™ Robotics for Its Flexible Robotic System [Yahoo! Finance]
HCA Healthcare, Inc. (HCA)
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Source: Yahoo! Finance
US FDA Grants Investigational Device Exemption (IDE) to EndoQuest™ Robotics for Its Flexible Robotic System Houston, TX, Dec. 10, 2024 (GLOBE NEWSWIRE) -- The US Food and Drug Administration (FDA) has granted EndoQuest Robotics, Inc., a privately-held pioneer in the development of flexible endoluminal robotic technologies, an Investigational Device Exemption (IDE) for its pivotal colorectal clinical study, Prospective Assessment of a Robotic-Assisted Device in Gastrointestinal Medicine (PARADIGM) . [Link: https://clinicaltrials.gov/study/NCT06133387?term=endoquest&rank=1 ] This landmark multi-center, open-label, prospective study will evaluate EndoQuest's state-of-the-art Endoluminal Surgical (ELS) System's safety and performance in robotic endoscopic submucosal dissection (ESD) procedures for the removal of colorectal lesions. Fifty subjects will participate across five leading US healthcare institutions, including Brigham and Women's Hospital (Boston), Mayo Clinic (Scottsdale),
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