Intuitive Surgical, Inc. (Nasdaq: ISRG), 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 companys 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 worlds 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 companys 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.
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