FDA Clears iCE Neurosystems’ Brain Monitor
May 19, 2021
The FDA has granted iCE Neurosystems 510(k) clearance for its iCE-SG Subcutaneous Electrode device, a component of its already-cleared neuromonitoring platform.
The device enables healthcare staff to quickly obtain long-term, high-fidelity brain data at a patient’s bedside that can be used to inform clinical decisions.
The device can help patients in intensive care following a primary brain injury, as well as critically ill individuals suffering from cardiac arrest, heart failure or sepsis who are at risk of potential brain injury, the company said.