Smartphone Biosensor May Meet ISO/FDA Standard for Pulse Oximetry Monitoring

A photoplethysmography (PPG) biosensor present in millions of smartphones could potentially be approved by the US Food and Drug Administration (FDA) for pulse oximetry monitoring, according to study results published in CHEST.

Laboratory testing was conducted on a photoplethysmography (PPG) biosensor currently present in millions of Android phones. Accuracy and precision of readings obtained by patients using the app were compared to hospital reference devices using a rigorous statistical methodology.

The smartphone sensor with the app met International Organization for Standards (ISO) and FDA standards for pulse oximetry for reflective sensors, according to results from certified laboratory testing. The open label clinical arm of the study included 320 participants (ClinicalTrials.gov Identifier: NCT04233827). In the outpatient setting, test units gave 96.0% and 95.5% valid heart rate and oxygen saturation (SpO₂) readings, respectively. In the inpatient setting, these values increased to 97.9% in valid heart rate readings and 97.1% in valid SpO₂ readings.

No significant bias was found for the test units relative to the reference values in terms of heart rate in the inpatient setting. However, for SpO₂, the test units were significantly lower than the reference values.

“Our data shows the smartphone sensor with [the app] tested met laboratory FDA/ISO standards and could be used to obtain highly accurate and repeatable measurements across a varied population,” the study authors wrote” “Given the immediate practical medical importance of remote intermittent clinical pulse oximetry, Industry should be encouraged and supported to pursue full FDA/ISO approval of this smartphone sensor with [the app].”

Smartphone Biosensor May Meet ISO/FDA Standard for Pulse Oximetry Monitoring

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