FDA Clears New Brain Monitoring Electrode

A Novel Approach to Brain Monitoring Receives FDA Clearance

A regulatory route previously utilized for COVID-19 vaccines and therapeutics has now facilitated advancements in electroencephalography (EEG). This established brain-monitoring technique involves the placement of metal electrodes on the scalp to assess the brain’s electrical signals.

iCE Neurosystems Gains FDA Approval

On May 17th, iCE Neurosystems, a startup headquartered in Washington, D.C., announced a form of FDA approval for its subcutaneous electrode, known as iCE-SG. This device is engineered to monitor brain electrical activity from under the skin of the scalp.

This approval follows a 2020 Emergency Use Authorization (EUA) granted for iCE Neurosystems’ software platform, iCEWav. The platform was deployed in a hospital within the D.C. metropolitan area to monitor the brain activity of patients in medically induced comas during the COVID-19 pandemic.

Reimagining Traditional EEG

The iCE Neurosystems electrode and software represent a modernized approach to conventional EEG. The electrode is designed for prolonged placement beneath the scalp, enabling continuous analysis of brain activity.

The software component is created to integrate this data with crucial vital signs, such as heart rate and blood pressure. This integration provides a comprehensive physiological picture.

Comprehensive Data Integration

“We now have access to a substantial, high-fidelity, continuous, and integrated dataset encompassing both brain and bodily functions,” states Allen Waziri, a neurosurgeon and co-founder of the company.

“This capability allows for a deeper understanding of brain activity, facilitating timely clinical decisions and ultimately improving patient outcomes.”

Company Background and Funding

iCE was established in 2017 by Waziri and his colleagues during his residency at Columbia University Medical Center. As of 2021, the company comprises nine full-time employees.

To date, iCE Neurosystems has secured a total of $4.5 million in funding, including a recent $2.95 million investment from private investors in April 2021.

A Platform for Continuous Brain Monitoring

The subcutaneous electrode and software combination are integral to iCE Neurosystems’ broader vision: the creation of a comprehensive platform for continuous brain monitoring.

Potential Applications and Research

Continuous monitoring offers potential benefits in various clinical scenarios. A 2019 study published in the New England Journal of Medicine indicated that specialized EEG monitoring could detect signs of consciousness in patients previously considered unresponsive.

This research was led by Jan Claassen, the director of Critical Care Neurology at Columbia, who also holds a co-founder and minority shareholder position at iCE Neurosystems.

Furthermore, a 2019 study suggested that continuous EEG monitoring correlated with reduced mortality rates in hospital settings. However, only 22,728 individuals out of over 7 million analyzed in the study had access to continuous EEG.

Expanding Access to Continuous Monitoring

Waziri aims to increase this number. He believes that subcutaneous electrodes are a crucial first step. The iCE-SG electrodes are designed for straightforward installation and do not necessitate the specialized technical skills typically required for traditional EEG preparation and administration.

Other researchers have also highlighted the complexities associated with utilizing and interpreting traditional EEG, which has hindered long-term monitoring efforts.

Device Duration and Ease of Use

FDA documentation indicates that the iCE-SG devices are approved for remaining under the skin for up to 14 days. However, Waziri reports achieving continuous brain activity monitoring for as long as 35 days.

In comparison, a conventional long-term EEG analysis may typically last several days.

“The procedure is akin to inserting an IV,” Waziri explains. “A routine clinician can place these electrodes at the bedside in under five minutes.”

Data Sharing and Collaborative Analysis

While the platform itself doesn’t resolve the need for expertise in data interpretation, Waziri’s solution involves making the data readily shareable.

Data collected within a hospital is stored securely in the cloud. Hospitals can also choose to share this data on the iCECloud Knowledge platform with other medical institutions.

“Data from participating institutions is aggregated and made accessible to all users of our system,” he states. “Our objective is to essentially crowdsource the analysis of the data.”

Regulatory Pathway and Approvals

iCE Neurosystems has pursued two distinct forms of FDA approval for its software and electrode.

Both the electrode and the full platform received FDA premarket approval through the 510(k) pathway. This pathway allows a medical device to enter the market without further FDA review if it is substantially equivalent to existing products (in this case, traditional EEG).

The iCEWav system received 510(k) approval in March 2020, and the electrode followed in March 2021.

Expedited Approval and Safety

The 510(k) pathway is among the most rapid routes for bringing a medical device to market. However, it has faced scrutiny for not requiring safety or efficacy testing through clinical trials.

Waziri asserts that there “have been no complications” reported with the devices.

Early Clinical Application During the Pandemic

In early 2020, iCE Neurosystems was conducting trials with iCEWav when the pandemic began. Some COVID-19 patients required intensive cardiopulmonary support, necessitating medically induced comas.

Technicians typically utilize EEG to monitor these patients, but the D.C.-area hospital requested a trial run of iCEWav, seeking a long-term method for monitoring brain activity without frequent technician visits.

“They had our system in place because we were running a clinical trial in patients with cardiac arrest, and they asked us if they could use the system for monitoring their critically ill COVID patients. They actually applied to the FDA and the FDA granted emergency use authorization for the software,” Waziri says.

Future Research and Expansion

As of now, iCE Neurosystems has not published peer-reviewed data from the trial at the D.C.-area hospital, but Waziri indicates that two manuscripts are forthcoming.

Currently, iCE Neurosystems is focused on expanding the deployment of its devices to additional hospitals. They are in discussions with five more hospitals and plan to initiate a Series A funding round in mid-2022.