AI Cardiology • FDA SaMD Class II • BLE Holter Patch Ingestion

CardioPulse: AI Arrhythmia Early-Warning Platform

How Ajath HealthTech architected a low-latency companion app and edge neural inference engine to detect Atrial Fibrillation and Ventricular Tachycardia in real time across 500,000+ active patients.

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64% Turnaround Reduction
500k+ Active Monitored Patients
99.6% AFib Sensitivity
Class II FDA 510(k) Cleared

Clinical Impact Summary

CardioPulse Telemetry & AI
Verified Metrics
64% Faster Triage Holter patch ECG review turnaround dropped from 72 hours to under 26 hours.
Zero Latency Drift On-device CoreML & TensorFlow Lite models classify beats in under 12 milliseconds without cloud round-trip.
100% Epic EHR Ingestion Arrhythmia episode clips auto-populate cardiologists' Epic InBasket via SMART on FHIR.
The Engineering Challenge

The Challenge: Bottlenecks in Traditional Cardiac Holter Monitoring

Traditional 14-day Holter patches generated gigabytes of uncompressed biometric data that required manual technician review, delaying life-saving cardiac interventions for patients experiencing intermittent atrial fibrillation.

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Critical Latency Delays

Patients had to complete 14 days of recording before mail-in analysis, leaving dangerous ventricular tachycardias undetected in real time.

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Battery & Memory Constraints

Continuous Bluetooth streaming of raw 500Hz ECG waveforms drained mobile phone batteries within 6 hours, causing high patient non-compliance.

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FDA SaMD Class II Rigor

The AI algorithm required complete traceability, IEC 62304 Level C software architecture, and ISO 14971 medical risk management documentation.

The Ajath Architecture

The Technical Solution: Dual-Stage Edge & Cloud Telemetry

We engineered a hybrid architecture that balances extreme battery efficiency with instant clinical escalation.

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On-Device CoreML / TFLite Inference

Quantized 1D Convolutional Neural Network (CNN) running locally on iOS and Android to evaluate R-peak intervals, detecting AFib and PVC bursts in real-time with negligible CPU load.

CoreML 3.0 Quantized 1D-CNN < 12ms Beat Triage

Binary WebSocket Ingestion Cluster

When an arrhythmia episode is detected on the edge, the app opens a Protobuf-compressed WebSocket session, streaming the 30-second pre/post event strip directly to the cardiologist console.

Protobuf Codec WebSocket WSS Sub-150ms Stream
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SMART on FHIR InBasket Dispatch

Automated conversion of classified arrhythmia episodes into HL7 FHIR v4 Observation and DiagnosticReport resources, inserting actionable ECG caliper PDF strips into hospital EHR charts.

Epic InBasket HL7 FHIR v4 LOINC 8867-4

Looking to Build an FDA-Cleared Medical AI App?

Schedule a technical architecture call with our lead medical AI engineers to review your sensor protocols, neural model pipeline, and FDA 510(k) software requirements.

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