Press release summary
B-Secur launched an ECG Test System on Oct. 7 for developers and manufacturers of wearable electrocardiogram products. The company said the platform is intended to standardize how electrodes and completed devices are evaluated during development and production quality control.
The system pairs a test device with characterized electrode and subject cohorts, then scores signal quality on a scale from zero to 10. B-Secur said the analysis considers settling time, validated heartbeats and noise. The company is offering two configurations: ETS Electrode for comparing electrode materials and ETS Device for testing assembled wearable products.
B-Secur said its methodology draws on testing of more than 300 electrode materials. The release did not provide independent validation data or a detailed comparison with existing electrical and physiological test methods, so users will need to determine how the system fits their risk management, verification and acceptance criteria.
For laboratory and quality teams, the product targets a difficult source of variability in wearable monitoring: the combined effects of electrode materials, skin contact and device design on usable ECG signals. A reproducible scoring approach could help teams compare designs and document production checks, provided the method is validated for the intended device and population.
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