FDA clears text

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.

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