The US Food and Drug Administration (FDA) has granted 510 (k) clearance for AION Biosystems’ iTempShield device and software system.
The quarter-sized, skin-wearable device iTempShield leverages cloud-based software and proprietary algorithms and is intended for adults, and children aged five years and above.
Approved for over-the-counter sale, the device can be used in remote patient monitoring environments, hospitals, and out-patient healthcare facilities.
The platform is suitable for various clinical applications, including consumer home health, long-term care monitoring, post-surgical infection detection and oncology sepsis monitoring.
The low-profile iTempShield device sticks to the chest’s surface, unlike other wearables applied to the skin.
iTempShield’s accompanying remote monitoring platform ensures that patients and their healthcare providers receive notifications whenever the patient’s temperature surpasses a predetermined threshold set by a medical professional over a given period.
The unique adhesive it uses has been approved by the FDA and is suitable for even the most sensitive patient groups.
Furthermore, iTempShield can operate continuously for 60 days without needing recharging.
It is presently in use at Ellis Medicine’s Roswell Park Cancer Institute. Through the Smart City programme, the technology is being implemented broadly across the City of Schenectady.
AION Biosystems CEO Samara Barend said: “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.
“Our goal is to make remote patient monitoring so easy, accurate and cost-effective that anyone, anywhere can benefit from its life-saving capabilities.”