The US Food and Drug Administration (FDA) has granted 510(k) clearance to the AURA ICP Monitoring System from Branchpoint Technologies.
The system includes a fully implantable wireless intracranial pressure (ICP) sensor designed to provide mobile monitoring of ICP in brain-injured patients. The information gathered is then transmitted 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, according to the Irvine, Calif-based company, in a media release.
“The AURA ICP monitoring system is a groundbreaking and long-sought advancement that enables ICP monitoring without the need for a tethered connection between the patient’s brain and the bedside monitor,” says Dr Michael Muhonen, director of Neurosurgery and Medical Director of the Neuroscience Institute at Children’s Hospital of Orange County (CHOC), in the release.
“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.”
William Worthen, executive chairman at Branchpoint Technologies, adds that, “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. We are planning immediate commercial cases to gain early customer feedback while we explore strategic options for the technology.”
[Source(s): Branchpoint Technologies, PR Newswire]