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FDA Approved

NeuralLink Nexus

Model: AZ-NLX-4C | Series 4

High-bandwidth brain-computer interface for motor restoration and cognitive augmentation. Utilizes 1,024 flexible micro-electrodes with adaptive signal processing.

Channels1,024
PowerWireless Inductive
Latency< 2ms
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CE Marked

CardioSync Pacemaker

Model: AZ-CSM-9 | Series 9

Leadless transcatheter pacemaker with AI-driven rhythm optimization. Monitors hemodynamics and auto-adjusts pacing to prevent arrhythmia onset.

Battery Life15+ Years
Size12mm x 4mm
TelemetryBluetooth Medical
ðŸĶī
Clinical Trial

OsseoFlex Joint Replacement

Model: AZ-OFX-2 | Series 2

3D-printed porous titanium alloy joint with integrated strain sensors. Promotes osseointegration while tracking load distribution and wear in real-time.

MaterialTi-6Al-4V ELI
Integration94% Osseointegration
Sensors6-Axis IMU
📊
FDA Approved

VisceraMonitor Core

Model: AZ-VMC-1 | Series 1

Minimally invasive abdominal implant for continuous pH, temperature, and biochemical monitoring. Alerts clinicians to sepsis, inflammation, or organ stress.

Sampling10Hz Continuous
AlertsEdge AI Prediction
Lifespan8 Years
👂
Clinical Trial

Auralis Cochlear Implant

Model: AZ-ACL-3 | Series 3

Next-gen auditory implant with bone-conduction hybrid architecture. Features adaptive noise cancellation and direct neural mapping for high-fidelity sound restoration.

Frequency Range20Hz - 20kHz
Channels48 Independent
ChargingOvernight Wireless
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Pre-Clinical

VagusStim Regulator

Model: AZ-VRG-0 | Prototype

Closed-loop vagus nerve stimulation device for neurological and metabolic modulation. Uses biofeedback to automatically adjust pulse width and amplitude.

Stimulation0.1 - 5.0 mA
FeedbackHRV + Cortisol
StatusAnimal Studies

Certified for Clinical Deployment

All Aevum Zenth implantable systems undergo rigorous validation protocols, biocompatibility testing, and real-world longitudinal studies.

FDA & CE Certification

Full regulatory clearance for Class II and Class III medical devices across US and EU markets. ISO 13485:2016 certified manufacturing facilities.

Biocompatibility (ISO 10993)

All implant materials pass cytotoxicity, sensitization, irritation, and chronic toxicity screening. Pyrolytic carbon, medical-grade titanium, and Parylene-C coatings used.

Cybersecurity & HIPAA

End-to-end encryption for telemetry data. Zero-trust architecture for remote firmware updates. Full compliance with HIPAA, GDPR, and FDA SaMD guidelines.

Post-Market Surveillance

Continuous performance monitoring via secure cloud dashboards. Automated anomaly detection and proactive clinical alerts for optimal patient outcomes.