May 17, 2021

iCE Neurosystems Announces FDA 510(k) Clearance for Brain Monitoring Devices Used in Critical Illness

Devices are part of the iCEWav Neuromonitoring Platform which combines minimally invasive electrodes, integrated multiparametric data and custom cloud software to drive AI-based clinical decision support.  

WASHINGTON, DC, – iCE Neurosystems, a deep-tech startup that has created a revolutionary platform to diagnose and prevent brain injury in critically ill patients, today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the iCE-SG Subcutaneous Electrode device as a novel component of their previously cleared iCEWav Neuromonitoring Platform.

“While EEG has long been the gold standard for real-time monitoring of brain health, standard EEG requires specialized technical support and often provides poor quality data which profoundly limits the utility of this technique,” said Dr. Allen Waziri, neurological surgeon and CEO/Co-Founder of iCE Neurosystems. “iCE-SG Electrodes enable routine personnel at the bedside to record long-term, high-fidelity brain data that is optimized for immediate interpretation and clinical action.”

Initially applied with iCEWav under an FDA Emergency Use Authorization, subcutaneous electrodes were utilized by physicians in critically ill patients suffering from COVID-19 requiring advanced cardiopulmonary support. Resulting data were used to optimize sedative medications, provide real-time monitoring for secondary brain injury and treat otherwise undetectable seizures. Further data was acquired in a controlled clinical trial in patients suffering from anoxic brain injury following cardiac arrest, demonstrating superior durability and signal quality of subcutaneous electrodes when compared to standard EEG recording.

iCE Neurosystems estimates that up to 2.5 million Americans per year could benefit from their brain monitoring technology. In addition to those patients undergoing intensive care following a primary brain injury such as stroke, hemorrhage or trauma; critically ill individuals suffering from cardiac arrest, heart failure or sepsis, undergoing complex cardiac or vascular procedures are currently at risk for life-altering but potentially avoidable brain injury.

“Brain injury during critical illness is unfortunately quite common and could often be avoided with timely and targeted clinical intervention. However, such intervention requires data that is currently unavailable in the vast majority of cases. The consequences cost hospitals millions and patients much, much more,” said Waziri. “iCE-SG Electrodes in conjunction with the iCEWav Neuromonitoring Platform provide doctors and nurses with the ability to easily, safely, rapidly and effectively acquire brain and body data that will fundamentally change their ability to care for the brain in critically ill patients.”

This FDA clearance follows iCE Neurosystems’ recent acquisition of $2.95 million in seed funds from private investors to accelerate hospital adoption and expand data applications. Through the use of transformative technology, iCE Neurosystems is dedicated to advancing brain care for all Americans.

 

 

 

About iCE Neurosystems:

iCE Neurosystems is building the world’s largest unified brain and body data set using the iCEWav Neuromonitoring Platform. Integrating novel devices, next-generation software and big-data approaches, iCEWav provides doctors and nurses with revolutionary insight into brain health in real-time, saving patient lives and improving hospital outcomes.