CergenX

What CergenX does

CergenX is an Irish medical device company founded in 2021 as a spin-out from University College Cork (UCC) and the INFANT Research Centre, headquartered in Cork with offices in Dublin and Boston. The company develops AI-powered EEG analysis software, primarily through its flagship product CergenX Wave, an FDA Breakthrough-designated medical device that analyzes 10 minutes of 2-channel EEG recordings to provide automated, rapid assessment of newborn brain function and identify infants at highest risk of brain injury. The technology is built on a deep convolutional neural network trained on an exclusive license to the NEObase database, the world's most extensive curated repository of newborn EEG recordings (50,000+ hours from 202 babies), achieving expert-level seizure detection accuracy (AUC 0.982 on the Helsinki benchmark).

The company's AI capability is centered on proprietary algorithms developed over decades of neonatal EEG research at INFANT, with additional capabilities including automated discontinuity detection (AUC 0.980) and the open-source SPEED evaluation framework. CergenX holds ISO 13485 certification and complies with FDA 21 CFR Part 11, HIPAA, GDPR, and ICH-GCP standards, supporting multi-jurisdiction commercialization.

The business model combines hardware sales of the Wave device with cloud-based subscription services for ongoing AI updates, sold via enterprise B2B direct sales to hospitals, NICUs, neonatologists, and pediatric neurologists on a quote-based, multi-year contract basis. The company is pre-commercial, with a planned 2025 product launch targeting the EU, UK, and US markets. Total disclosed funding is approximately €8.7 million across a 2022 seed round, a 2023 private financing, and a 2023 DTIF consortium grant, supporting a team of 14 with stated expansion plans over the next 18 months.

Name

CergenX

Legal name

CergenX Limited

Website

https://cergenx.com

Company type

Private

Founded year

2021

Operating status

Operating

Headcount range

11–50 employees

Short description

CergenX is an Irish medical device company developing CergenX Wave, an AI-powered EEG analysis device that screens newborns for brain injury risk. Founded in 2021 as a UCC spin-out, the company targets hospitals and NICUs with a planned 2025 commercial launch across the EU, UK, and US.

Ownership category

akta.pro rank

Product category

Neonatal Neurological Diagnostic Devices

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Navigational, Measuring, Electromedical, and Control Instruments Manufacturing (33451)

SIC

Electromedical & Electrotherapeutic Apparatus (3845)

akta.pro primary industry

Neurological Monitoring (EEG, Seizure/Sleep/Neuro Wearables) (HLAHACAE)

akta.pro secondary industry

Epilepsy & Seizure Disorders (HLAKAIAB)

Keywords

• Neonatal brain monitoring
• EEG analysis software
• AI medical devices
• Newborn neurological assessment
• Cerebral palsy detection

Headquarters

HQ city

Cork

HQ country

Ireland

HQ region

Europe

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales, Infrastructure

Revenue model

1. Medical Device Sales: Sale of CergenX Wave medical device to hospitals and healthcare providers. Device is FDA breakthrough-designated and targets the neonatal brain injury screening market.
2. Software/SaaS Subscription: Cloud-based AI delivery model allows for ongoing software updates and subscription-based revenue stream for AI analysis services.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels7 records

Core offering

CergenX develops and sells CergenX Wave, an FDA Breakthrough-designated AI-powered medical device that analyses 10 minutes of 2-channel EEG recordings to identify newborns at highest risk of brain injury. The device provides automated, expert-level brain function assessment results in minutes without requiring specialist interpretation, enabling point-of-care neonatal neurological assessment in any hospital or NICU setting. Revenue is generated through device sales combined with cloud-based AI software subscriptions for ongoing analysis services.

Product overview

CergenX offers a single core product: CergenX Wave. This FDA Breakthrough Device-designated AI-powered medical device revolutionizes neonatal neurological assessment by analyzing 2-channel EEG recordings to identify newborns at highest risk of brain injury. The device delivers automated AI EEG assessment results in minutes, providing objective decision support for all clinicians—not just specialists. Wave is designed for simplicity and requires minimal training, making advanced neurological assessment accessible at the point of care in any healthcare setting.

Differentiator

Problem solved

Functional benefit

Brands

• Wave: FDA Breakthrough Device Designated AI-powered medical device for neonatal neuroprotective care that revolutionises the assessment of newborn brain function using 2-channel EEG analysis to identify newborns at highest risk of brain injury.

Products and services

• CergenX Wave FDA Breakthrough-designated AI-powered medical device that analyses 10 minutes of 2-channel EEG recordings to provide automated, objective assessment of newborn brain function and identify infants at highest risk of brain injury. Delivers results in minutes without requiring specialist EEG interpretation, designed for use by all clinicians in hospital and NICU settings. Combines proprietary hardware with cloud-based AI software that provides ongoing updates.

Quantifiable outcome

• Achieves expert-level accuracy in neonatal seizure detection (statistically indistinguishable from human experts)
• +4 more outcomes

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability6 records

Feature5 records

Partnerships

Six partnerships are on record, tiered minor and core.

• University of Notre DameminorStrategic or Co-development Partner · 1 January 2023Notre Dame ESTEEM Graduate Program capstone collaboration. Student Oscar Gleeson worked on commercialisation and GTM strategy for US market as capstone project, later joined as Commercialisation Manager.
• INFANT Research Centre, University College CorkcoreStrategic or Co-development Partner · 1 January 2021Deep research partnership providing foundational technology. AI algorithms built on decades of neonatal EEG research from INFANT Centre. Exclusive license to NEObase database. Prof. Geraldine Boylan serves as both CergenX CSO and Director of INFANT Centre.
• UCC InnovationcoreStrategic or Co-development Partner · 1 January 2021UCC Innovation guided company through spin-out procedure and granted exclusive license for NEObase database rights in 2021.
• Irish Neonatal Health Alliance (INHA)minorStrategic or Co-development PartnerCollaboration with patient advocacy organization founded by Mandy Daly. INHA focuses on advocacy, awareness, education, research and support for families affected by preterm birth and neonatal health issues.
• Hope for HIEminorStrategic or Co-development PartnerGlobal patient advocacy organization for families affected by Hypoxic Ischemic Encephalopathy (HIE). Executive Director Betsy Pilon collaborates on patient-centred innovation approach.
• Helsinki University HospitalTechnology or IntegrationOpen-source neonatal seizure detection benchmark dataset from Helsinki used for validating CergenX AI model performance (AUC of 0.982 on their dataset).

Scale indicators6 records

Recent moves6 records

Expansion highlights6 records

Market position

Weaknesses6 records

Competitive moat5 records

Key highlights8 records

Customer concentration

• Xx.com/CergenX
• GitHubgithub.com/CergenX
• LinkedInlinkedin.com/company/cergenx

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles11 records

Funding overview

Funding rounds2 records

Investors1 record

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about CergenX