Intuitive Surgical has submitted a premarket notification to the US Food and Drug Administration (FDA) for its robotic-assisted, catheter-based platform, designed to navigate through 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 US.
Intuitive Surgical, headquartered in Sunnyvale, Calif., is the pioneer and a global leader in robotic-assisted, minimally invasive surgery. Intuitive Surgical develops, manufactures and markets the da Vinci surgical system.
Source: Company Press Release.