Aion wins FDA clearance for skin-wearable body temperature monitoring device

The iTempShield system received FDA clearance. [Image from Aion Biosystems]Aion Biosystems announced today that it received FDA 510(k) clearance for its iTempShield device and software system.

iTempShield received approval for use in adults and children five years of age and older. It covers use in hospitals, outpatient facilities, remote patient monitoring environments and over-the-counter sales.

Boston-based Aion designed the quarter-sized, skin-wearable monitoring device with support from cloud-based software and proprietary algorithms. It enables the continuous measurement of body temperature for a variety of clinical applications. That includes oncology sepsis monitoring, post-surgical infection detection, long-term monitoring and consumer home health.

The company says iTempShield’s accuracy comes in four times higher than an oral thermometer.

More about the Aion Biosystems iTempShield device

iTempShield adheres to the surface of the skin …

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