Disclaimer: The PPG arrhythmia and AFib function is a wellness screening tool only. It cannot be used for medical diagnosis, treatment, or disease assessment. All detection results are for reference. End products must carry mandatory disclaimers before market launch.
Vositone’s multi-channel PPG AFib screening algorithm delivers reliable arrhythmia detection for wearable OEM partners. This technical specification document outlines algorithm architecture, clinical validation data, hardware prerequisites, operating limits, API output, power consumption, regulatory routes and OEM integration workflows. This document targets hardware product managers, embedded engineers and compliance teams who build smartwatches and health bracelets.
This AFib detection solution works alongside ECG monitoring modules on wearable hardware. You can learn more about our wearable cardiac sensing hardware from our guide on Vositone Smartwatch Professional ECG & Blood Oxygen Monitoring. For general biometric accuracy tuning techniques, review our Biometric Accuracy Enhancement Guide 2025.

The Vositone arrhythmia detection engine runs a multi-stage pipeline directly on wearable MCU. Raw optical PPG signals go through five sequential processing blocks before final arrhythmia classification.
First, the signal preprocessing module removes baseline drift, motion artifacts and ambient light noise. Next, the Signal Quality Index (SQI) evaluates waveform integrity; low-quality segments are discarded to avoid false readings. Then the engine extracts IBI (inter-beat interval) values from qualified PPG pulses. After that, a hybrid classifier combining rule-based logic and lightweight machine learning analyzes IBI patterns to flag atrial fibrillation or irregular rhythm events. Finally, the event logger packages detection results, timestamps and SQI scores for local storage or BLE transmission.
This on-device design reduces cloud dependency and preserves user health data privacy. It also cuts latency so wearable devices can return arrhythmia alerts within seconds after a valid measurement window.
Vositone completed clinical validation cooperation with partner hospitals under controlled resting conditions. The test cohort covers different age groups, skin tones and body types to reflect real-world wearable use cases.
表格
| Metric | Benchmark (Resting State) | Notes |
|---|---|---|
| AFib Sensitivity | ≥93% | Stable resting measurement |
| AFib Specificity | ≥91% | Excludes non-AFib irregular rhythms |
| Valid Signal SQI Threshold | 0.7 | Readings below threshold will not trigger diagnosis alerts |
| Minimum Measurement Duration | 30 seconds | Shorter windows significantly reduce accuracy |
Performance drops sharply under heavy movement, cold peripheral circulation or poor wrist fit. Our smart wearable devices future personal technology article explains how next-gen wearables will improve motion artifact suppression for biometric sensors.
OEM hardware must meet these baseline specs to run the full arrhythmia detection algorithm. Vositone reference designs VO539 and VO547 are pre-validated for this algorithm stack.
Best measurement results occur when users stay still, keep the watch snug on the wrist and maintain normal skin temperature. Several scenarios degrade detection reliability. Heavy exercise, hand shaking, low blood perfusion and loose wearing positions will raise false positive and false negative rates.
This PPG algorithm cannot detect ventricular arrhythmia, myocardial infarction or other severe cardiac disorders. It does not replace hospital ECG equipment or professional cardiologist diagnosis. OEM teams must print this limitation clearly in user manuals and on device UI prompts.
The algorithm outputs structured data via BLE GATT profiles for paired mobile apps. Available fields include timestamp, heart rate value, SQI score, rhythm classification result and confidence level. The wearable can store up to 50 arrhythmia event logs locally.
The companion mobile app can compile historical screening records and export PDF health reports. OEM developers can customize alert thresholds and report templates according to brand requirements.
Two working modes are available for OEM configuration: periodic sampling and continuous monitoring. Periodic sampling consumes only microamps between measurement windows and preserves long battery life. Continuous PPG scanning increases power draw and shortens watch runtime.
OEM engineers can tune sampling frequency to balance detection responsiveness and battery performance. Power tuning is one core topic in our smartwatch buying guide for OEM product design.
Product teams have two major market positioning options: wellness-only screening or medical-grade certification. Wellness mode has simpler documentation requirements, while medical classification requires full technical file submission.
For US market access, review guidance from the FDA Digital Health Center of Excellence. For EU sales, MDR Class IIa applies if the product is positioned as a medical device. OEM partners must complete risk analysis, clinical evaluation and post-market surveillance documents.
External link 1: https://www.fda.gov/medical-devices/digital-health-center-excellence
Technical papers on PPG-based AFib detection provide further background for your R&D team.
External link 2: https://ieeexplore.ieee.org/
Vositone delivers algorithm firmware packages, API documents and porting support for OEM customers. Engineers can enable or disable the arrhythmia detection module at compile time. Key parameters including SQI thresholds and alert rules can be customized.
OTA firmware channels support future algorithm version upgrades after mass production. Our technical team provides L1 and L2 engineering support during prototype testing and mass trial phases.
Current production version: v2.3
Future roadmap:
PPG tracks pulse volume changes on the wrist instead of direct cardiac electrical signals. It can screen for irregular pulse patterns linked to AFib, but it cannot capture full ECG waveforms. Hospital ECG remains the gold standard for formal cardiac diagnosis.
No. The algorithm itself does not automatically grant medical certification. Your end product needs full clinical evaluation, risk files and regulatory submissions under FDA or EU MDR rules. Vositone provides technical documentation to support your certification work.
Body movement creates optical noise that distorts PPG waveforms. The algorithm will automatically reject low-quality signals when SQI drops below threshold to reduce false alerts.
It depends on your MCU memory and PPG sensor configuration. Submit your hardware schematic to our engineering team for a quick compatibility review.
The core arrhythmia calculation runs locally on the watch. Data upload happens only if your mobile app design enables cloud sync. OEMs retain full control over data transmission architecture.
We provide firmware packages, API manuals, integration guides and engineering consultation. For full confidential specification sheets, submit an NDA request to our business team.
Request our full confidential technical specification by signing an NDA. Contact Vositone’s OEM engineering team to discuss PPG arrhythmia detection integration for your next wearable project.
Useful Links:
GSMA Intelligence
IEEE Xplore Digital Library
U.S. FDA Digital Health Center of Excellence
PubMed Central (NIH)
Statista - Wearable Technology
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