Aion Biosystems has announced that its iTempShield device and software system has obtained FDA 510(k) clearance. This regulatory approval covers its use in adults and children aged five and above, encompassing various settings such as hospitals, outpatient facilities, remote patient monitoring environments, and over-the-counter sales.
The Boston-based company, Aion, collaborated on the creation of this skin-wearable monitoring device, which is roughly the size of a quarter, alongside cloud-based software and proprietary algorithms. This innovative system facilitates the continuous tracking of body temperature for diverse clinical applications, including monitoring for oncology sepsis, detecting post-surgical infections, conducting long-term monitoring, and supporting consumer home health.
The company emphasises that the iTempShield device offers a fourfold increase in accuracy compared to traditional oral thermometers.
The iTempShield adheres to the skin surface on the chest and can operate for up to 60 days without requiring recharging. This extended battery life enhances compliance and qualifies the device for reimbursement in hospital and health system contexts. Aion suggests that approved remote patient monitoring CPT codes by CMS can generate revenue for healthcare providers while delivering benefits to patients.
Designed for seamless integration into the healthcare ecosystem, the device comes with a remote monitoring platform. This platform ensures that both patients and clinicians receive alerts if the temperature surpasses a predetermined threshold. Aion has developed this platform for effortless integration into medical records systems within hospitals or physician practices, as well as remote patient monitoring systems.
Aion aims to primarily concentrate on early infection detection among cancer patients and long-term care residents using the iTempShield device.
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