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Physical AI Clinical Infrastructure · Class IIa

ZoyeMed

Version 3.0 · 2026

A single, room-deployable clinical terminal that acquires objective physiological ground truth across 120+ sensor modalities, validates inputs before inference, reasons longitudinally across the patient's full history, and escalates to a human clinician under a governed protocol - entirely on-device, without cloud dependency.

Class IIa Medical Device Edge AI Inference Longitudinal Multimodal AI Institutional Deployment
120+Sensor ModalitiesClinical-grade, on-device validated
0Cloud RequiredAll primary inference on-device
18,224PMCF ConsultsMar 2025 - Feb 2026
9M+Patient Episodes
15yrClinical Lineage
IIaDevice Class
ZoyeMed 3.0

**Actual Product may have variations in shape, color, size and configuration based on production batch/Year

120+ ModalitiesSensor Integration
On-Device InferenceNo Cloud Dependency
Longitudinal AIFull Patient History
FHIR R4 OutputEMR Interoperability
Class IIa RegulatedCE Electrical · NYCE
Clinician in LoopGovernance Layer

Sensor Matrix

120+ modalities.
One terminal.

Every modality is clinically validated against reference equipment. Inputs are quality-gated before inference. These are not wellness sensors - they are clinical instruments.

Cardiovascular
18 modalities
12-Lead ECGBlood PressureSpO₂Heart RatePPGPulse WaveformCardiac EnzymesTroponin-IBNPLipid ProfileHomocysteineD-Dimer
Respiratory
12 modalities
SpirometryFEV1 / FVCDigital StethoscopyRespiratory RatePeak FlowAuscultation AIBreath SoundsCO Monitoring
Metabolic & Biochemistry
28 modalities
HbA1cBlood GlucoseHaematology CBCLiver FunctionKidney FunctionThyroid TSHCRPElectrolytesUric AcidUrinalysisHsCRPFerritin
Ophthalmological
8 modalities
Fundus ImagingVisual AcuityIOP TonometryColour VisionDiabetic Retinopathy AIPupil Response
Otological & ENT
6 modalities
OtoscopyTympanometryAudiometryThroat ImagingNasal Endoscopy
Dermatological
8 modalities
DermatoscopeLesion Analysis AIThermal ImagingSkin Tone CalibrationWound Assessment

The complete modality list - 120+ sensors across biochemistry, haematology, immunofluorescence, AI-vision rapid diagnostics, neurological, and reproductive health - is available in the Technical White Paper.

System Architecture

Five layers.
One clinical operating system.

ZoyeMed is structured as a layered clinical operating system. Each layer has a distinct function, runs at a different tempo, and can independently refuse, escalate, or block. No single model. No black box.

L1 · SENSORIUM
Physical Acquisition Layer
120+ clinically validated sensor modalities - biochemistry, haematology, immunofluorescence, 12-lead ECG, digital stethoscopy, thermal imaging, spirometry, dermatoscope, urinalysis, AI-vision rapid diagnostics. All measurements time-aligned to sub-50ms precision within encounter windows. Operator-guided acquisition protocol ensures clinical quality.
Hardware
L2 · AMYGDALA
Safety & Data-Quality Gate
Scores data sufficiency across all acquired modalities before any inference is permitted. Refuses output when inputs are inadequate - below clinical quality thresholds, contaminated by artefact, or logically inconsistent. Anonymises patient identifiers on-device before any data leaves the terminal. The architecture of refusal: the system knows when it does not know enough.
Safety Gate
L3 · CORTEX
Longitudinal Multimodal Model
Per-modality encoders fuse acquired signals into a visit embedding. A proprietary sequence engine processes visit embeddings across the patient's full clinical history - tracking biomarker velocity and acceleration, not just point values. Outputs calibrated ICD-10 / ICD-11 differential diagnoses, urgency classification, risk flags, and next-action recommendations. PCT patent filed Q1 2026.
PCT Patent
L4 · THALAMUS
Governance & Audit Layer
Per-jurisdiction policy bundles enforce data residency, consent scope, protocol routing, and operator credentialing. Immutable cryptographic audit trail for every inference, every clinician action, and every override. Clinician sign-off is required for all consequential clinical actions. Autonomous prescribing is architecturally prohibited - not just policy-prohibited.
Governance
L5 · INTELLIGENCE
Population Intelligence Layer
Anonymised, edge-aggregated signal layer derived from terminal network data. Produces real-time epidemiological outputs: disease incidence, drug resistance patterns, nutritional deficiency distributions, outbreak signals, occupational risk clusters. All data derived from clinically measured ground truth - not patient self-report. Configurable per-jurisdiction data residency.
Population AI

Clinical Use Cases

Deployed for five distinct institutions.

ZoyeMed's deployment model is institutional. Each partner type has specific clinical objectives, regulatory requirements, and commercial structures.

Sovereign healthcare infrastructure.

For Ministries of Health and national public-health agencies. ZoyeMed extends clinical-grade access into geographies where physicians are unavailable - and simultaneously builds a real-time epidemiological intelligence layer over the deployment. Every terminal is a clinical encounter point and a population health sensor simultaneously.

Active deployment: Mexico under the Más Salud programme (Grupo Salinas / Elektra network). Colombia under a multi-year institutional agreement.

Discuss National Programme →
Access expansion
Clinical-grade encounters in geographies without physicians. Operator-staffed terminals supervised remotely by specialist clinicians.
National health intelligence
Real-time epidemiological signal from objective sensor data - disease incidence, drug resistance, nutritional deficiency, outbreak detection.
Data sovereignty by architecture
PHI anonymised at edge. In-country data residency for aggregated data. Configurable per-jurisdiction governance.
Standardised clinical quality
Same diagnostic depth at every deployment site, regardless of operator background or local infrastructure quality.

Extend reach.
Standardise quality.

For hospital networks and integrated health systems. ZoyeMed distributes diagnostic depth into spoke catchments while preserving central clinical authority, audit, and specialist oversight. FHIR R4 output integrates natively with existing HIS and EMR systems. Specialist time is leveraged across five to ten times more encounters per hour.

Typical deployment: Fleet of 100+ units across distributed network sites. Full operator training programme. Ongoing PMCF support.

Discuss Network Deployment →
Distributed diagnostic reach
Full point-of-care lab and 120+ modality examination at any spoke site. Specialist time leveraged across many more encounters.
FHIR R4 interoperability
FHIR R4 output, ICD-10/11, SNOMED CT, LOINC, RxNorm. Native integration with existing HIS, EMR, and PACS systems.
Specialist leverage
Remote specialists oversee 5-10x more encounters per hour. AI handles the routine; specialists handle the consequential.
Auditable governance
Immutable audit trail. Every AI inference, clinician disposition, and override - logged with cryptographic integrity.

Objective data.
Longitudinal trajectory.

For health insurers and payer organisations. ZoyeMed replaces self-reported health declarations with objective sensor-derived data at the point of clinical encounter, enabling risk detection before threshold-based diagnosis, longitudinal member analytics, and verified clinical event records that cannot be retrospectively fabricated.

Key capability: Longitudinal trajectory model surfaces drift toward chronic conditions earlier than snapshot diagnostics - enabling earlier intervention at lower long-term cost.

Discuss Payer Integration →
Objective pre-authorisation data
Sensor-acquired ground truth at the point of encounter. Eliminates the gap between self-report and clinical reality.
Early risk detection
Longitudinal trajectory model surfaces drift toward chronic conditions before threshold-based diagnosis. Earlier intervention, lower cost.
Fraud reduction
Verified, sensor-anchored clinical events with cryptographic audit trail. Cannot be retrospectively fabricated.

Workforce health,
on-site.

For industrial, occupational health, and large corporate campus operators. ZoyeMed deploys clinical-grade health monitoring at industrial scale - across mines, factories, oilfields, smart cities, and large campuses - without requiring site evacuation for worker health encounters.

Key capability: Real-time detection of occupational disease patterns - respiratory function shifts, biomarker cluster anomalies, occupational toxin exposure indicators - across the full cohort.

Discuss Industrial Deployment →
Occupational risk surveillance
Real-time detection of occupational disease patterns - respiratory shifts, biomarker cluster anomalies, toxin exposure indicators.
Workforce health monitoring
Comprehensive periodic health encounters for every worker. Longitudinal cohort tracking across years of employment.
Regulatory compliance
Auditable, FHIR-interoperable record of workforce health monitoring. Meets occupational health standards in regulated industries.

Healthcare at
points of commerce.

For large retail and commercial operators embedding healthcare access within existing consumer footprints. The Más Salud programme with Grupo Salinas demonstrates this at scale: ZoyeMed terminals deployed across Elektra retail locations throughout Mexico, transforming points of daily commerce into clinical-grade diagnostic environments accessible to millions.

Active deployment: Elektra network, Mexico City and expanding. 18,224 PMCF-documented consultations through February 2026.

Discuss Commercial Deployment →
Existing footprint activation
Deploy clinical access within retail locations, pharmacies, and commercial centres. No new real estate required.
Population-level access
Retail network scale brings clinical access to millions who would not otherwise seek it. Más Salud · Grupo Salinas is the live proof.
Operator-staffed, remotely supervised
Trained operators run the terminal encounter. Remote specialists provide clinical oversight. No physician required on-site.

Interoperability

Speaks every clinical
language.

ZoyeMed outputs structured, standards-compliant clinical data. It integrates with existing HIS, EMR, PACS, and national health platforms without requiring custom connectors at the clinical data layer.

ZoyeMed 3.0 Output
FHIR R4 ICD-10 ICD-11 SNOMED CT LOINC RxNorm HL7 DICOM OpenEHR
FHIR R4
HL7 FHIR R4 Resources
Full FHIR R4 resource output for every encounter - Patient, Observation, DiagnosticReport, Condition, Procedure, and MedicationRequest resources. Native integration with Epic, Cerner, Meditech, and all major FHIR-compliant platforms.
ICD-11
ICD-10 / ICD-11 Differential Output
Calibrated differential diagnosis output in ICD-10 and ICD-11 terminology. Probability-ranked, with confidence scores and supporting evidence references for each differential.
SNOMED
SNOMED CT, LOINC & RxNorm
Clinical findings coded in SNOMED CT. Laboratory results coded in LOINC. Medication references in RxNorm. No post-processing required for integration into terminology-compliant HIS platforms.
Security
PHI & Data Residency
PHI anonymised at edge before any transmission. Cryptographic audit chain. Per-jurisdiction policy bundles. Configurable data residency - aggregate data stays in-country where required.

Deployment Model

Built for institutions.
Not consumers.

ZoyeMed deploys as a fleet. Typical programmes begin at 100+ units. Per-client configuration handles all jurisdiction-specific compliance at the governance layer - without branching the codebase.

Deployment Timeline
From signed agreement to first clinical encounters is typically 90-120 days, covering logistics, in-country regulatory clearance, operator training, and HIS integration.
  • Week 1-4: Contract, logistics, in-country customs
  • Week 5-8: Site preparation, IT integration
  • Week 9-12: Operator training programme
  • Week 13-16: Go-live, supervised period, PMCF initiation
Operator Model
Each terminal is staffed by a trained operator - a healthcare worker or clinical assistant who guides the patient through the encounter and flags for remote specialist review.
  • Operator certification programme included
  • Remote specialist supervision layer
  • AI handles structured data acquisition
  • Specialist reviews findings and signs off
Configuration Per Jurisdiction
Every ZoyeMed deployment runs the same codebase. Jurisdiction-specific requirements are handled at the governance layer - no custom builds, no forked codebases.
  • Per-jurisdiction data residency policy
  • Configurable consent scope and workflow
  • Local language support
  • Regulatory dossier support for in-country clearance
Active Deployments
Current institutional programmes across three countries, with expansion under active commercial discussion across MENA, Southeast Asia, and Latin America.
  • Mexico - 44 units · Más Salud / Grupo Salinas · multi-phase contract to 300
  • Colombia - multi-year agreement · first unit Bogotá Q1 2026
  • Malaysia - entity registration · MDEC · data residency confirmed
  • Expansion: MENA · India · SEA under discussion

Market Position

How ZoyeMed compares to existing categories.

The digital health market has sorted into four operating categories. Each addresses one dimension of clinical care delivery. ZoyeMed is a fifth - a physical AI clinical infrastructure layer that integrates all four.

Capability Chatbot / LLM AI Telemedicine EHR Analytics Diagnostic Kiosk ZoyeMed 3.0
Direct sensor acquisition ✗ None ✗ None ✗ None ~ 3-8 sensors ✓ 120+ modalities
Clinical-grade validated inputs ✗ No ✗ No ~ Depends on EHR ~ Partial ✓ Full validation gate
On-device edge inference ✗ Cloud only ✗ Cloud only ✗ Cloud only ~ Limited ✓ Full edge inference
Longitudinal patient memory ✗ No ~ Session only ✓ Yes ✗ No ✓ Full longitudinal AI
Safety gate / refusal ✗ No ✗ No ✗ No ✗ No ✓ Multi-stage gate
Clinician governance layer ✗ No ✓ Yes ~ Partial ~ Optional ✓ Mandatory sign-off
FHIR R4 interoperability ✗ No ~ Varies ✓ Yes ✗ Rarely ✓ Full FHIR R4
Medical device classification ✗ None ~ Software only ~ Software only ~ Limited scope ✓ Class IIa
Offline / no-connectivity operation ✗ No ✗ No ✗ No ~ Partial ✓ Full offline operation

A thirteen-platform, seven-axis competitive analysis is available in the Technical White Paper - The Category Nobody Else Is Building.

Clinical Evidence

Evidence before claims.

18,224 PMCF-documented consultations. A published Post-Market Clinical Experience Report. A regulatory programme across five jurisdictions. The clinical record precedes the market claim.

18,224PMCF ConsultationsDocumented Mar 2025 - Feb 2026 across Mexico, Colombia & Malaysia
9M+Patient EpisodesAcross the full platform lineage since 2010
15yrClinical LineageGlocal Healthcare India 2010 through ZoyeMed 3.0
3Active CountriesMexico · Colombia · Malaysia · expanding
Tier 1
Clinical White Paper - February 2026
Overview of ZoyeMed 3.0 clinical architecture and PMCF summary. Freely accessible, no form required.
Download PDF →
Tier 1
SSRN Preprint
Peer-reviewed academic preprint on ZoyeMed clinical AI architecture. Available via email.
Request SSRN Link →
Tier 2
Technical White Paper
"The Category Nobody Else Is Building" - 13-platform competitive analysis, full PMCF data. Corporate email required.
Tier 3
Full PMCF Report + Financial Model
Complete post-market clinical data and commercial model. NDA + discovery call required.
Request Briefing →

Regulatory & IP Status

Class IIa regulated.
Five-jurisdiction programme.

ZoyeMed 3.0 is a regulated medical device. Regulatory classification is a design constraint - it forces clinical quality at the input layer, not a marketing label applied after the fact.

Certified
CE Electrical
European electrical safety standard. Current certification covering the ZoyeMed terminal hardware platform.
Certified
NYCE Mexico
Mexican electrical safety and telecommunications standard. Required for institutional deployment across Mexican territory.
In Process
CE Medical Device (MDR)
European Medical Device Regulation - Class IIa. System-level conformity assessment. PMCF dataset is primary clinical evidence.
In Process
FDA 510(k)
US FDA premarket notification - Class II. Clinical programme actively generating evidence for submission.
In Process
COFEPRIS Mexico
Mexican Federal Commission for Protection against Sanitary Risk - medical device classification for full commercial clinical deployment.
In Process
INVIMA Colombia
Colombian national food and drug surveillance authority - medical device classification for full commercial deployment.
In Process
CDSCO India
India Central Drugs Standard Control Organisation - medical device classification. In process alongside Malaysia MDEC registration.
Filed
PCT Patent
Patent Cooperation Treaty - longitudinal multimodal clinical AI architecture. Filed Q1 2026. International coverage across PCT member states.

ZoyeMed® is a registered trademark of Zoya Technologies LLC. Full regulatory dossier available to qualified regulatory reviewers under NDA. Contact our regulatory team →

The Zoya Technologies Product Suite

Five products.
One clinical AI ecosystem.

ZoyeMed 3.0 is the flagship clinical terminal. Around it sits a connected suite of products - a patient app, a diagnostic chair, a population sentinel, and a clinical smartwatch - all sharing the same longitudinal AI layer, the same data architecture, and the same principle: sense before you reason.

zoyel Patient Apps

Product 02 · Patient App

Zoyel.Health

The Patient Layer of the Clinical AI Ecosystem

Zoyel.Health is the patient-facing application that connects directly to the ZoyeMed terminal encounter. When a patient completes a clinical encounter on ZoyeMed 3.0, their structured clinical findings, biomarker trajectory, and clinician notes are available in the app - giving them a longitudinal view of their own health, not just a snapshot from today.

The app is the patient's window into their own clinical AI record. It surfaces biomarker trajectories, appointment history, clinician notes, medication reminders, and - critically - alerts derived from the longitudinal AI layer when trajectory patterns warrant attention.

iOS & Android Live · Available Now Longitudinal Health Record FHIR R4 Patient Access
📈
Biomarker Trajectory View
Not just today's readings - the full trajectory of each biomarker across every encounter. Velocity and trend visible at a glance.
🔔
AI-Derived Health Alerts
When the longitudinal AI layer detects a biomarker pattern warranting review, the patient receives a notification to book a follow-up encounter.
🏥
Encounter Records & Clinician Notes
Structured encounter summaries from every ZoyeMed visit - clinician-signed findings, differential notes, and next-action recommendations.
🔒
Patient-Controlled Data Sharing
Patients control what is shared with other providers. FHIR R4 export available for portability to any compatible health system.
Ecosystem Link ZoyeMed 3.0 Encounter data Zoyel.Health App Patient trajectory view

Product 03 · Diagnostic Chair

ZoyeRest Chair

Passive Diagnostic Infrastructure · In Development

ZoyeRest is a diagnostic resting chair that acquires continuous ambient biosignal data without operator intervention. A patient sits. The chair senses. The data flows into the longitudinal AI layer. No formal encounter required - continuous background monitoring that fills the clinical record between active ZoyeMed terminal sessions.

Designed for waiting rooms, rehabilitation units, post-operative recovery areas, corporate wellness facilities, and any environment where patients spend extended time at rest. ZoyeRest turns passive time into clinical signal.

In Development Passive Sensing Continuous Monitoring ZoyeMed Ecosystem
💺
Zero-Effort Acquisition
No operator required. No patient action required. Embedded sensors in the chair structure passively acquire cardiovascular, respiratory, and temperature signals throughout the rest period.
📊
Continuous Longitudinal Feed
Data from each rest session feeds directly into the ZoyeMed longitudinal AI layer - enriching the patient's clinical trajectory between formal ZoyeMed encounters.
🏥
Clinical Environment Integration
Designed for waiting rooms, rehabilitation units, post-op recovery, corporate wellness, and pharmacy consultation zones - anywhere rest time can be converted to clinical signal.
Anomaly Detection
Sustained cardiovascular or respiratory anomalies during rest trigger an alert to the clinical oversight team - before the patient's formal encounter.
Ecosystem Link ZoyeRest Chair Passive biosignal Longitudinal AI Layer ZoyeMed 3.0 context
zoyeRest
zoyel Sentinel

Product 04 · Population Sentinel

Zoyel Sentinel

Ambient Population Health Intelligence · In Development

Zoyel Sentinel is a stationary monitoring device designed for public and institutional environments - transport hubs, shopping centres, stadiums, healthcare waiting areas, and smart city deployments. It passively aggregates anonymised ambient biosignals from crowds and public spaces, feeding a real-time population health intelligence layer without any individual-level interaction or data capture.

Think of it as a population-level early warning system: detecting anomalous biosignal cluster patterns that may indicate an emerging respiratory outbreak, a heat-stress event, or unusual physiological stress across a cohort - before it shows up in hospital admissions data.

In Development Ambient Monitoring Population Intelligence Privacy Preserving
📡
Passive Crowd Biosignal Aggregation
Aggregates anonymised biosignal patterns from individuals in range - without device pairing, opt-in, or individual data capture. Population signal only.
🦠
Outbreak Early Warning
Detects anomalous respiratory, thermal, or cardiovascular cluster patterns consistent with emerging infectious disease events - days ahead of hospital-based surveillance systems.
🏙
Smart City & Public Health Integration
Designed for Ministry of Health and smart city deployments. Network of Sentinels produces a continuously updated, geographically distributed health signal layer.
🔐
Privacy by Architecture
No individual identification. No device pairing. No personal data stored. Signal is aggregated at source - only population-level patterns transmitted to the intelligence layer.
Ecosystem Link Sentinel Crowd biosignal Population AI Layer Ministry / Smart City dashboard

Product 05 · Wearable

Zoyel Watch

Clinical-Grade Smartwatch · In Development

Zoyel Watch is a clinical-grade wearable that continuously feeds the longitudinal AI layer between formal ZoyeMed terminal encounters. Consumer smartwatches produce wellness signals. Zoyel Watch produces clinical signals - validated, calibrated, and integrated into the same AI architecture that powers the ZoyeMed terminal.

The watch is not a standalone product. It is the continuous sensing layer that fills the clinical record between episodes - tracking biomarker trajectories in real time, alerting patients and clinicians when a trajectory warrants an encounter, and providing the longitudinal AI model with a denser, more temporally resolved signal than terminal-only data alone can deliver.

In Development Continuous Wearable Clinical-Grade Sensing ZoyeMed Ecosystem
Clinical-Grade Continuous Sensing
Not wellness-grade PPG - validated cardiovascular, SpO₂, temperature, and activity signals at clinical accuracy levels, calibrated against ZoyeMed reference measurements.
🔗
Longitudinal AI Integration
Continuous watch data feeds the same longitudinal AI layer as terminal encounter data - giving the AI model a far richer temporal signal between encounters.
⚠️
Trajectory-Based Alerts
When continuous wearable data shows a biomarker trajectory shifting toward clinical concern, an alert routes through Zoyel.Health to the patient and their assigned clinician.
🏥
Pre-Encounter Calibration
Before a formal ZoyeMed encounter, watch data provides the AI model with a 30-day trend baseline - enabling the terminal AI to contextualise new readings against a richly populated longitudinal record.
Ecosystem Link Zoyel Watch Continuous signal Longitudinal AI ZoyeMed pre-context
zoyewatch

Connected Ecosystem

All five products share
one longitudinal AI layer.

The Zoya Technologies product suite is not a collection of independent devices. Every product feeds data into the same longitudinal AI architecture - building a richer, more temporally dense clinical record for every patient in the ecosystem.

🏥
ZoyeMed 3.0
120+ sensors
Clinical encounter
Zoyel Watch
Continuous wearable
Inter-encounter signal
🪑
ZoyeRest
Passive ambient
Rest-state signal
📡
Sentinel
Population ambient
Public health signal
📱
Zoyel.Health
Patient layer
Trajectory view
🧠
Longitudinal AI Layer
All signal streams
unified here
All five products feed into the same proprietary longitudinal multimodal AI layer - the same architecture that powers ZoyeMed 3.0's clinical inference. The richer the signal across the ecosystem, the more precise the trajectory model.

Next Steps

Ready to discuss
deployment?

For institutional procurement, government health programmes, technical white paper access, or investor discussions - our team responds within two business days.

ZoyeMed® is a registered trademark of Zoya Technologies LLC. Class IIa Medical Device. CE Electrical · NYCE Mexico certified. CE-MDR, CDSCO, COFEPRIS, INVIMA in process. Longitudinal multimodal model architecture subject to PCT patent filing 2025-26. Technical disclosure available under NDA.