Medical technology company AION Biosystems has secured the US Food and Drug Administration (FDA) 510 (k) clearance of its iTempShield device and software system for professional and retail settings.
iTempShield is a skin-wearable device that continuously measures body temperature for a range of clinical applications. These include post-surgical infection detection, monitoring of oncology sepsis, long-term care monitoring, and consumer home health.
The FDA has approved the quarter-sized device for use on adults and children aged five and older in healthcare settings such as hospitals, outpatient clinics, remote patient monitoring settings, and retail sales to consumers.
The iTempShield comes with a cloud-based software and proprietary algorithms to enable precise and continuous temperature measurement for up to 60 days.
The US-based AION Biosystems said that the device’s main focus will be on early infection detection in cancer patients and long-term care residents.
The iTempShield is designed to stick to the surface of the chest skin unlike any other skin-applied wearable and can function for up to 60 days without recharging.
According to the medical technology company, its battery life aids in patient compliance and makes the device qualified for device reimbursement in hospital and health system settings using the Centers for Medicare & Medicaid Services (CMS)-approved remote patient monitoring CPT codes. These codes will also help generate recurring revenue for providers.
AION Biosystems claimed that iTempShield’s accuracy is four times higher than an oral thermometer as it calculates body temperature using artificial intelligence (AI)-powered algorithms.
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.”
The medical technology firm said that the device can seamlessly fit into the healthcare ecosystem.
The companion remote monitoring platform of the iTempShield sends alerts to patients and clinicians if their temperature exceeds above a predetermined threshold over a predetermined period.
Suitable for remote patient monitoring systems and hospital or physician medical records systems, the platform’s adhesive has FDA clearance and can be used on sensitive patient groups as well, said the firm.
