Intuitive Surgical Submits New Robotic-Assisted Platform to FDA for Obtaining Lung Biopsies
Intuitive Surgical, Inc., the pioneer and a global technology leader in robotic-assisted, minimally invasive surgery, today announced it has submitted a premarket notification to the U.S. Food and Drug Administration (FDA) for the company’s new flexible robotic-assisted, catheter-based platform, designed to navigate through very small lung airways to reach peripheral nodules for biopsies.
Lung cancer is the world’s leading cause of cancer deaths. The majority of suspicious lesions found in the lung are small and difficult to access, which can make obtaining a diagnosis challenging.
Intuitive brings more than two decades of leadership in robotic-assisted surgical technology and solutions to this innovative new platform, which supports the company’s leadership in the advancement of minimally invasive care.
Premarket notification is one of the regulatory processes that the FDA uses to review information about medical devices before they are allowed to be marketed in the U.S.
See a full video discussing this announcement here.
Press Release by Intuitive Surgical
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