Medical Wearable: FDA-Cleared Remote Patient Monitoring Device for Cardiac Care
End-to-end development of an FDA 510(k) cleared wearable ECG monitor with 14-day battery life, achieving 99.2% arrhythmia detection accuracy and enabling remote monitoring for 50,000+ cardiac patients.
The Challenge
A US-based digital health startup needed to develop a medical-grade wearable ECG monitor that could continuously monitor cardiac patients for up to 14 days, detect arrhythmias in real-time, and achieve FDA 510(k) clearance for the US market.
Our Solution
We developed a complete medical-grade wearable ECG monitoring system including custom hardware, embedded firmware, mobile app, cloud platform, and all regulatory documentation required for FDA 510(k) clearance.
System Architecture
End-to-end medical IoT architecture designed for regulatory compliance, reliability, and scalability.
Custom Hardware Design
| MCU | nRF52840 (BLE 5.0, DSP capable) |
| AFE | ADS1292R (24-bit, medical-grade) |
| Electrodes | Ag/AgCl dry electrodes |
| Battery | 180mAh Li-Poly (rechargeable) |
| Dimensions | 55mm x 25mm x 8mm |
| Weight | 18g (with adhesive) |
| Protection | IP67, IEC 60601-1 certified |
Firmware Architecture (IEC 62304 Class B)
- FreeRTOS-based architecture with watchdog supervision
- Real-time 256Hz ECG sampling with DMA
- On-device R-peak detection and HRV calculation
- QRS complex classification (normal, PVC, PAC)
- BLE GATT service for ECG streaming
- Encrypted firmware OTA updates
- Comprehensive fault detection and logging
- Battery management with 1% accuracy
On-Device AI for Arrhythmia Detection
We implemented a lightweight neural network on the device for real-time arrhythmia screening, with cloud-based analysis for detailed diagnosis.
Beat Classification
1D CNN (Convolutional Neural Network)
99.2% for VEB/SVEB detection
Atrial Fibrillation Detection
LSTM with attention mechanism
97.8% sensitivity, 98.5% specificity
< 2 second detection delay
Signal Quality Assessment
Random Forest classifier
96% noise/artifact detection
Implementation Timeline
Results & Impact
The device achieved FDA clearance on first submission and has since been deployed to monitor over 50,000 cardiac patients, with clinical outcomes significantly better than traditional Holter monitoring.
Arrhythmia Detection Accuracy
vs 94% for traditional Holter
Battery Life
vs 24-48 hours for competitors
Patient Compliance
vs 68% for chest-strap monitors
Time to FDA Clearance
vs industry avg 18-24 months
Manufacturing Cost
Below $35 target
Patients Monitored
First 18 months post-launch
“Rapid Circuitry didn't just build us a device - they helped us navigate the complex regulatory landscape and delivered a product that exceeded our clinical requirements. The FDA clearance on first submission was remarkable.”
CEO & Co-Founder
Client Digital Health Startup