FDA Clears Branchpoint Technologies’ AURA Intracranial Pressure Monitoring System

Branchpoint Technologies, a company dedicated to providing accurate, reliable, and cost-effective mobile solutions for intracranial pressure (ICP) monitoring, announced that the United States Food and Drug Administration (FDA) has granted 510(k) clearance for its AURA ICP Monitoring System. The AURA ICP Monitoring System includes a fully implantable and wireless intracranial pressure (ICP) sensor that, for the first time ever, enables truly mobile ICP monitoring in brain-injured patients. Unlike traditional ICP monitoring systems requiring a cabled connection with the patient’s brain, the AURA system is completely wireless in both power and transmission of patient data directly to a bedside monitor. AURA enables continuous telemetric monitoring of parenchymal ICP including continuous ICP waveforms and eliminates the need for additional capital equipment investments.
 
“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,” said Dr. Michael Muhonen, Director of Neurosurgery and Medical Director of the Neuroscience Institute at Children’s Hospital of Orange County (CHOC). “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.”
 
William Worthen, Executive Chairman at Branchpoint Technologies, said, “Innovation in the ICP monitoring space has been lacking and long overdue and this is a significant milestone for Branchpoint and for patients whom require intracranial pressure monitoring. Branchpoint has done an amazing job conceiving, developing and bringing about FDA clearance for this disruptive technology. We are planning immediate commercial cases to gain early customer feedback while we explore strategic options for the technology.”