AION gets FDA nod for iTempShield skin-wearable device and software platform
31 Aug 2023
iTempShield is a skin-wearable device that measures body temperature for a range of clinical applications for adults and children aged five and older in different healthcare settings
iTempShield is said to be four times more accurate than an oral thermometer. (Credit: Matteo Fusco on Unsplash)
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.
For more details,please visit the original website
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Indications
Targets
-Drugs
-Chat with Hiro
Hot reports
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.