Aion wins FDA clearance for wearable body temp monitoring device

August 30, 2023 By Sean Whooley

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.

iTempShield adheres to the surface of the skin on the chest and can function without recharging for up to 60 days. Its battery life aids compliance and makes the device eligible for device reimbursement in hospital and health system environments. CMS-approved remote patient monitoring CPT codes can help generate revenue for providers while benefitting patients, Aion says.

The company said it designed the device for ease of use and a seamless fit into the healthcare ecosystem. Its accompanying remote monitoring platform ensures patients and clinicians receive alerts if their temperature exceeds a set threshold. The company built the platform for easy integration into hospital or physician medical records systems and remote patient monitoring systems.

Aion said in a news release that it intends to primarily focus on early infection detection in cancer patients and long-term care residents.

“Our iTempShield device and platform can literally mean the difference between getting an antibiotic prescription at home and a trip to the emergency room that ends in the ICU,” said Samara Barend, Aion Biosystems CEO. “Our goal is to make remote patient monitoring so easy, accurate and cost-effective that anyone, anywhere can benefit from its life-saving capabilities.”

Filed Under: 510(k), Diagnostics, Digital Health, Food & Drug Administration (FDA), Health Technology, Regulatory/Compliance, Software / IT Tagged With: Aion Biosystems, FDA