Clinical Validation of a Smartphone-based Handheld ECG Device: A Validation Study

Area of Science:

• Biomedical Engineering
• Cardiology
• Digital Health

Background:

• Remote cardiac monitoring is a key component of telemedicine.
• The proliferation of wireless electrocardiography (ECG) devices necessitates accuracy and reliability validation.

Purpose of the Study:

• To validate the accuracy and reliability of the Nabz Hooshmand-1 handheld ECG device.
• To compare its performance against a standard GE MAC 1200 ECG system.

Main Methods:

• 300 inpatients underwent simultaneous 10-second resting ECGs using both devices.
• Analysis focused on Lead I ECG parameters and 6-limb lead ECG morphologies.
• Cardiologist review assessed rhythm, rate, morphology, and intervals.

Main Results:

• High-quality ECGs were obtained from 297 patients for Lead I and 281 for 6-limb leads.
• No significant differences were found between devices; major abnormalities were not missed.
• Overall morphology compatibility was 98%, with highest accuracy in Lead I.

Conclusions:

• The Nabz Hooshmand-1 handheld ECG is highly accurate for rhythm detection, comparable to the GE MAC 1200.
• It demonstrates acceptable sensitivity for diagnosing critical arrhythmias and interval abnormalities.
• The device is safe for screening and follow-up, despite potential usability challenges for some elderly patients.