Branchpoint Technologies' Aura Intracranial Pressure Monitoring System Receives FDA 510(k) Clearance
May 31, 2018—Branchpoint Technologies announced that the US Food and Drug Administration has granted 510(k) clearance for its Aura intracranial pressure (ICP) monitoring system.
According to the company, the Aura ICP monitoring system includes a fully implantable and wireless ICP sensor that enables truly mobile ICP monitoring in patients with brain injuries. The Aura system is completely wireless in both power and transmission of patient data directly to a bedside monitor. The device enables continuous telemetric monitoring of parenchymal ICP including continuous ICP waveforms and eliminates the need for additional capital equipment investments.
Michael Muhonen, MD, commented in Branchpoint's announcement, "The Aura ICP monitoring system is a ground breaking and long-sought advancement that enables ICP monitoring without the need for a tethered connection between the patient's brain and the bedside monitor."
Dr. Muhonen, who is Director of Neurosurgery and Medical Director of the Neuroscience Institute at Children's Hospital of Orange County in Orange, California, continued, "With traditional ICP monitoring systems, patient mobility within the hospital is cumbersome and product dislodgement and malfunction is common. Aura solves these problems, facilitates better ICP vigilance throughout the hospital and will benefit our patients immediately. Longer term, I am equally excited by the potential of the Aura platform in combination with a shunt for better hydrocephalus management."