'It's almost like placing an IV': Brain monitoring electrode receives FDA 510(k) clearance

·5 min read

An FDA pathway that’s greased the gears for COVID-19 vaccines and drugs has paved the way for something else: a new take on electroencephalography (EEG), the established brain-monitoring technique in which metallic electrodes are placed on the scalp to measure the brain’s electrical activity.

On May 17, DC-based startup iCE Neurosystems announced a version of FDA approval for a subcutaneous electrode called iCE-SG, designed to monitor the brain’s electrical activity from beneath the skin of the scalp. That electrode comes on the back of a 2020 Emergency Use Authorization (EUA) for iCE Neurosystems’ software platform called iCEWav, which was used in a D.C. area hospital to monitor the brain activity of patients in medically-induced comas during the Covid-19 pandemic.

iCE Neurosystems electrode and software are, essentially, a new take on traditional EEG. The electrode is designed to sit beneath the scalp for days and analyze brain activity, and the software component is designed to integrate that data with vital signs like heart rate or blood pressure.

“For the first time we've got this massive, high-fidelity, continuous, integrated data set from both brain and body,” says Allen Waziri, a neurosurgeon and company co-founder. “That allows us to really understand what's happening in the brain to drive timely clinical decisions, and fundamentally change outcomes for these patients.”

iCE was founded by Waziri and colleagues from his time as a resident at Columbia University Medical Center in 2017. As of 2021, the company has nine full-time employees, and has raised a total of $4.5 million, including a recent round of $2.95 million from private investors in April 2021.

The subcutaneous electrode and software combination is part of iCE Neurosystems bigger picture: to create a full platform for continuous monitoring of the brain.

There are examples of use cases where continuous monitoring may prove beneficial. For instance, a 2019 New England Journal of Medicine study suggested that specialized EEG monitoring might detect signs of consciousness in otherwise unresponsive patients. That study was authored by Jan Claassen the director of Critical Care Neurology at Columbia who is also co-founder and minority shareholder at iCE Neurosystems.

Another 2019 paper suggests that continuous monitoring via EEG was associated with fewer deaths in hospitals. But only 22,728 of the over 7 million people analyzed in the study had access to continuous EEG.

Waziri’s aim is to increase that number. Subcutaneous electrodes, he’s betting, are a first step. The iCE-SG electrodes should be easy to install and don’t require the technical expertise usually required to prepare and administer an EEG, explains Waziri. Other scientists have also noted technical expertise needed to use and interpret traditional EEG is cumbersome and has stood in the way of long-term EEG monitoring.

FDA approval documents note that the iCE-SG devices are approved to remain beneath the skin for 14 days, but Waziri says he’s obtained continuous monitoring of brain activity for up to 35 days. A long-term EEG analysis, by comparison, might last several days.

“It's almost like placing an IV,” Waziri says. “Basically a routine clinician at the bedside can place these in under five minutes.”

On the other hand, the platform alone can’t address the need for expertise to interpret this data. Waziri’s answer to that question is to make this data shareable.

Within a hospital, data collected by platform is stored on the cloud. However, a hospital could opt into sharing data on another platform iCECloud Knowledge with other medical institutions.

“From participating institutions, all the data we collect gets put in there and is made available to anyone who is using our system,” he says. “Our goal is to almost kind of crowdsource the analysis of the data.”

So far, iCENeurosystems has pursued two forms of FDA approval for the software and the electrode.

The electrode and the full platform have received FDA premarket approval through the 510(k) pathway – a type of pre-market approval that allows a medical device to go to market without additional FDA review because it’s substantially similar to other products already on the market (In this case, that tech is a traditional EEG). The iCEWav system was granted 510(k) approval in March 2020 and the electrode received it in March 2021.

This pathway is one of the most expedient ways to get a medical device onto the market, but has also faced criticism because it doesn’t require a device to be tested for safety or efficacy through clinical trials. Waziri says there “haven’t been any complications” from the devices.

Additionally, iCEWave has done time in the clinical setting in a major D.C. hospital, though Waziri won’t disclose which one.

In early 2020, the DC based startup iCE Neurosystems was in the midst of testing iCEWav when the pandemic hit. Some Covid-19 patients required intense cardiopulmonary support that required use of medically induced comas. Technicians typically use EEG to monitor these patients, but iCE Neurosystems also received a trial run, says Waziri, as the hospital was looking for long-term methods of monitoring patients brain activity without having technicians visit multiple times per day.

“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.

So far Waziri and iCENeurosystems hasn’t published any peer-reviewed data from that trial at the D.C. area hospital, but he says the company has two forthcoming manuscripts.

Meanwhile, Waziri says that iCE Neurosystems is working towards getting more devices into more hospitals. He says they’re in talks with an additional five hospitals, with the goal of beginning a Series A funding raise in mid 2022.

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