# Neonatal EEG MOnitor (NEMO) Phase IIb

> **NIH NIH R44** · QUASAR, INC. · 2024 · $979,895

## Abstract

Abstract
Neonatal seizures occur in over 14,000 newborns annually in the US, and are frequently
associated with long-term deleterious consequences including intellectual disability, epilepsy,
and other neurodevelopmental disabilities. Electroencephalography (EEG) is the only reliable
means of detecting seizures; however, many Neonatal Intensive Care Units (NICUs) do not
have the capability to do EEG recordings due to the lack of skilled EEG technicians to apply gel-
based electrodes to delicate neonatal skin and acquire clean signals.
Under NIH SBIR funding, Quantum Applied Science and Research (QUASAR), a leader in
noninvasive sensor technology, in collaboration with Children’s National Hospital (CNH), a top
ranked pediatric hospital, has been developing a Neonatal EEG MOnitor (“NEMO”) device
intended as a reliable and easy-to-use EEG system that will increase availability of neonatal
EEG monitoring to hospitals that typically lack this capability. The NEMO device takes
advantage of QUASAR’s innovative dry sensing technology combined with a soft cap that is
designed for minimal impact on the infants’ wellbeing and ease of use in the hospital
environment. NEMO will lead to more neonates being screened and treated, and thus to shorter
hospital stays and improved outcomes.
Under Phase I and Phase II of this project, QUASAR and CNH have validated QUASAR’s dry
electrodes for the neonatal monitoring application in a NICU environment, demonstrating their
signal quality was comparable to that of wet electrodes, and built a prototype NEMO headset.
The main goal of the proposed Phase IIb effort is to finalize the NEMO device, validate its
performance on neonates in the NICU environment, and obtain 510(k) clearance for it. In order
to accomplish this goal, QUASAR will work with ProPharma, a regulatory consultant firm, to
establish current Good Manufacturing Practices (cGMP) and finalize the NEMO device under
cGMP. QUASAR will then complete Safety Testing, and in collaboration with CNH will conduct
a Clinical Validation to obtain the necessary data for a 510(k) submission. The final step in the
project will be a product launch in partnership with medical device manufacturers and
distributors.

## Key facts

- **NIH application ID:** 10918107
- **Project number:** 5R44MH135741-05
- **Recipient organization:** QUASAR, INC.
- **Principal Investigator:** Neil J McDonald
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $979,895
- **Award type:** 5
- **Project period:** 2012-08-15 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10918107

## Citation

> US National Institutes of Health, RePORTER application 10918107, Neonatal EEG MOnitor (NEMO) Phase IIb (5R44MH135741-05). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10918107. Licensed CC0.

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