NeuroDx Medical delivers sub-microvolt clinical EEG hardware with built-in HL7/DICOM/FHIR integration, independently validated under IEC 60601-2-26 and cleared by FDA 510(k) K221839.
Product Lineup
Standalone or all together. Premium medical devices on an integrated export platform.
You capture every clinical event with confidence because NeuroDx amplifiers maintain input noise below 0.4 μV RMS with CMRR above 110 dB — independently validated under IEC 60601-2-26 at clinical scale.
Learn MoreYou eliminate months of integration projects because HL7 ORM/ORU, DICOM Encapsulated PDF, and FHIR R4 are standard features on every NX system — not paid add-ons requiring separate implementation contracts.
Learn MoreYou reduce reviewer fatigue and missed ictal events because the NX-128 embeds FDA-cleared real-time AI spike detection operating with end-to-end latency under 2 ms — no post-processing delay.
Learn MoreYou access US, EU, Korean, and 14 additional fast-track markets from a single device procurement because NeuroDx holds concurrent FDA 510(k), CE MDR Annex IX, and KFDA Class II registrations.
Learn MoreYou protect your capital investment across the full device lifecycle because NeuroDx provides lifetime firmware updates and a 48-hour service SLA across 22 countries — with no subscription fee or end-of-life cutoff.
Learn MoreYou serve every monitoring environment without multiple vendor relationships because NeuroDx covers home ambulatory EEG (72-hour IP22) through 128-channel pre-surgical mapping with OR-grade isolation in a single portfolio.
Learn MoreNeuroDx Medical manufactures three complementary clinical EEG systems covering the full spectrum of neurodiagnostic care — from bedside hospital monitoring and intraoperative use to long-term ambulatory home studies. All systems share a unified cloud review platform with HL7/DICOM/FHIR integration, SOC 2 Type II security, and lifetime firmware support.
Export Solutions
Reduce time-to-market with proven export solution frameworks.
The NX-64 streams 64-channel video EEG to a cloud review platform with shift handoff annotations, cutting turnaround time by eliminating manual file transfers between neurologists.
View SolutionThe NX-128 delivers 128-channel coverage with FDA-cleared AI spike detection at under 2 ms latency, providing the ictal onset localization data that surgical planning requires.
View SolutionThe NX-14's IP22-rated cap applies in under 8 minutes and records for 72 hours at home, increasing study compliance without requiring overnight hospital admission.
View SolutionThe NX-128's microsecond-accurate event marking and MEG/3T MRI synchronization enable multichannel cognitive and seizure research without post-hoc temporal alignment.
View SolutionNX-128's OR-grade isolation and sub-2 ms end-to-end latency deliver evoked potential waveforms in real time, supporting somatosensory and motor pathway monitoring during active surgery.
View SolutionOur Process
Step-by-step guidance through every stage of the export journey.
Contact NeuroDx Medical with your target clinical application, required channel configuration, target import country, and regulatory timeline. Our medical affairs team responds within 1 business day.
We deliver a customized proposal covering product configuration, EXW unit pricing, production lead time, and a full regulatory documentation package — FDA 510(k) letter, CE MDR certificate, ISO 13485 certificate, and IEC 60601 test reports.
Evaluate NX system performance in your clinical environment. NeuroDx Medical provides a supervised demo unit with application training, signal quality benchmarking, and EHR integration testing at your site or via remote session.
Confirm order with a 30% deposit. Production runs in our ISO 13485-certified facility in Bundang, Seongnam. Pre-shipment inspection by an accredited third party is available on request.
NeuroDx Medical ships with a complete documentation package — commercial invoice, certificate of origin, and all regulatory certificates. On-site installation and clinical staff training is included for hospital orders.
Success Stories
Hear why global medical device companies choose us.
Sub-microvolt signal quality should not be reserved for the top academic hospitals. NeuroDx was built to make that precision available at any clinical scale — eliminating the diagnostic ambiguity that delays treatment for patients in neurology wards worldwide.
Founded in 2014 by a senior R&D team from a 30-year Korean medical device manufacturer, NeuroDx inherited concurrent FDA, CE MDR, and KFDA regulatory experience without inheriting outdated hardware architecture or proprietary software lock-in.
HL7, DICOM, and FHIR interface specifications are published and standard on every device — no proprietary protocols. Every specification on our datasheets is independently verifiable under IEC 60601-2-26. Firmware updates are free for the operational life of every device.
By 2030, the majority of EEG monitoring will occur outside the hospital. NeuroDx builds hardware and cloud infrastructure for that future — ambulatory, cloud-coordinated, and AI-assisted from signal capture to diagnostic report.
Global Market
Korean medical device manufacturers hold 18% global share in clinical EEG.
Industry Insights
The clinical EEG market is transitioning from hospital-centric installations toward distributed monitoring architectures — ambulatory devices enabling home sleep studies and long-term epilepsy surveillance, connected to cloud platforms where neurologists and sleep specialists collaborate remotely. AI-assisted spike detection is shifting from research feature to clinical standard; FDA-cleared implementations are now required for pre-surgical epilepsy evaluation workflows at academic centers. Tele-neurology expansion in underserved markets — ASEAN, the Middle East, and Latin America — is creating institutional demand for turnkey EEG systems requiring minimal local technical support: integrated HL7/FHIR connectivity, lifetime firmware maintenance, and sub-48-hour service SLAs. Korean manufacturers holding concurrent FDA, CE MDR, and KFDA clearances are positioned to supply these markets faster than incumbents bound by longer regulatory transition timelines.
Certifications & Trust
From international regulatory certifications to global partnerships — every step verified.
Who We Serve
Expanding global markets together with medical device companies of all types.
B2B — Hospital neurology departments, clinical research institutions, and medical device distributors
FAQ
We answer every question about medical device export.
Yes. NeuroDx Medical is registered with the Korean FDA (KFDA) as a Class II medical device manufacturer and holds ISO 13485:2016 certification from an accredited third-party body. The company was founded in 2014 and has exported clinical EEG systems to 22 countries since 2018, with annual export volume estimated at $8–12M.
NeuroDx Medical holds FDA 510(k) clearance K221839 for clinical electroencephalography. This clearance covers the NX-64, NX-14, and NX-128 product lines for use in US clinical and hospital environments, cleared for patients age 2 and above.
NeuroDx Medical actively exports to 22 countries. Primary markets include the United States, Germany, Japan, Vietnam, and Saudi Arabia. The company also serves France, the United Kingdom, Thailand, Brazil, and Mexico. KFDA certification enables fast-track approval in 14 additional international jurisdictions.
The NX-64 Clinical EEG System has an MOQ of 1 unit for direct hospital orders and 5 units for distributor pilot programs. Both the NX-14 Ambulatory EEG and the NX-128 High-Density EEG have an MOQ of 1 unit for all order types.
Lead times from order confirmation are: NX-14 Ambulatory EEG — 4 weeks; NX-64 Clinical EEG System — 6 weeks; NX-128 High-Density EEG — 8 weeks. All times apply from receipt of a 30% deposit at NeuroDx Medical's ISO 13485-certified facility in Bundang, Seongnam.
Yes. All NX-series systems include HL7 ORM/ORU, DICOM Encapsulated PDF, and FHIR R4 integration as standard features at no additional cost. NeuroDx Medical provides integration documentation and remote technical support for connection to Epic, Cerner, and all HL7-compliant EHR and PACS environments.
Each device ships with a full regulatory documentation package: FDA 510(k) K221839 clearance letter, CE MDR Annex IX certificate, KFDA Class II registration, ISO 13485:2016 certificate, IEC 60601-1 and IEC 60601-2-26 test reports. SOC 2 Type II and HIPAA alignment documentation for the cloud platform is available on request.
Yes. The real-time AI spike detection feature on the NX-128 High-Density EEG is covered under FDA 510(k) clearance K221839. It operates with end-to-end latency under 2 ms and is indicated for pre-surgical epilepsy evaluation at academic medical centers and epilepsy surgery programs.
NeuroDx Medical provides a 48-hour service SLA across all 22 active export countries, including remote diagnostic support and on-site service coordination. Firmware updates are provided at no charge for the full operational life of every device — no annual subscription required.
Yes. The NX-14 Ambulatory EEG is rated IP22 for home-environment use. Clinical staff can complete cap application in under 8 minutes, and the device records for 72 continuous hours (168 hours with the extended battery pack) — enabling long-term epilepsy monitoring and home sleep studies outside the hospital.
Contact our medical affairs team for a full technical proposal, complete regulatory documentation, and on-site demonstration scheduling.
Contact Us
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