Home » Auris’ Monarch Platform Receives 510(K) Clearance
Auris’ Monarch Platform Receives 510(K) Clearance
Devices Submissions and Approvals
The FDA approved Auris’ Monarch system, a flexible endoscopic technology that can be used by physicians to diagnose lung cancer.
The device is cleared by the FDA for diagnostic and therapeutic bronchoscopic procedures and is assisted by computer navigation based on 3D models of the patient’s lung anatomy.
The device allows the user to access hard-to-reach, small peripheral nodules, using a controller-like interface to direct the Monarch system’s robotic endoscope to the periphery of the lung.