On Aug. 28, 2024, OxiWear announced it received FDA 510(k) clearance for its oxygen data collection device, an ear pulse oximeter designed for continuous, real-time measurement of blood oxygen saturation (SpO2) and pulse rate.
About the OxiWear System
The OxiWear System is a non-invasive wearable device that provides continuous data collection in adult and adolescent patients while still and in motion. It is worn on the helix of the ear with an adjustable clip-on mechanism and works across all skin types.
The system consists of a wearable, charger and mobile application. The wearable is a wireless, reusable ear pulse oximeter intended to measure SpO2 and pulse rate based on the amount of transmitted, reflected and scattered light through the ear. It’s powered by a lithium-ion battery and is recharged with the accompanying portable charger.
Using a Bluetooth connection, the wearable transmits data to the smartphone mobile app. The app provides live data monitoring, historical data for clinical review and text alerts.
According to the FDA approval letter, OxiWear is intended for spot-checking and/or continuous data collection in clinical and home environments.
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