AION Receives FDA Clearance for Its iTempShield Skin-Wearable Device and Software Platform for Professional and Retail Environments

August 30, 2023 |

5 min read

AION Biosystems, a medical technology company dedicated to dramatically expanding the use of remote patient monitoring, has received U.S. Food and Drug Administration 510 clearance of its iTempShield™ device and software system.

Technology Designed for Multiple Applications, with Initial Focus on Early Infection Detection and Treatment

BOSTON--(BUSINESS WIRE)-- AION Biosystems, a medical technology company dedicated to dramatically expanding the use of remote patient monitoring, has received U.S. Food and Drug Administration (FDA) 510 (k) clearance of its iTempShield™ device and software system. iTempShield is approved for use on adults and children five years of age and older in hospitals, out-patient healthcare facilities, remote patient monitoring environments, and for over-the-counter sale to consumers.

This quarter-sized, skin-wearable device is supported by cloud-based software and proprietary algorithms. The platform enables continuous measurement of body temperature for a variety of clinical applications such as oncology sepsis monitoring, post-surgical infection detection, long-term care monitoring, and consumer home health. AION Biosystems will primarily focus on early infection detection in cancer patients and long-term care residents.

Unlike any other skin-applied wearable, the low-profile iTempShield adheres to the surface of the skin of the chest. iTempShield can function without recharging for up to 60 days, aiding patient compliance. The battery life also makes iTempShield eligible for device reimbursement in hospital and health system environments via CMS approved remote patient monitoring CPT codes, which will generate recurring revenue for providers while benefitting patients.

Body temperature becomes elevated very early in patients who are developing an infection, and is the single most important physiologic parameter in predicting sepsis. As a result, AION BioSystems has intensely focused on measuring temperature more accurately than any other skin-applied device currently cleared by the FDA for medical and consumer use. iTempShield achieves this groundbreaking accuracy – it is 4x more accurate than an oral thermometer¹ – by calculating body temperature using a sophisticated library of AI-powered algorithms.

iTempShield is currently in use at Ellis Medicine’s Roswell Park Cancer Institute. The technology is also being deployed broadly across the City of Schenectady through an innovative Smart City program.

“iTempShield has the potential to be a ‘game changer’ for the management of cancer patients and other immunocompromised populations who are at heightened risk of infection,” said Dr. Nicholas Montalto, chief medical officer, Ellis Medicine. “By providing accurate continuous body temperature over a meaningful period of time, it allows us to keep our eyes on our patients wherever they are so that we can detect and treat infection before it becomes life-threatening.”

The standard of care for cancer patients at risk for infection is to take their oral temperature when they feel unwell. By the time they take their oral temperature, infection has often significantly progressed. In addition, oral and other kinds of thermometers vary in accuracy, and many individuals do not know how to take oral temperature correctly. Early infection detection can mean life or death for severely immune compromised patients. For those with sepsis, every hour delay of antibiotics means an eight percent increase in the risk of death.² In fact, 60 percent of cancer patient deaths are related to infection, and nine percent are caused by sepsis.^{3, 4}

Patients have already benefitted from iTempShield.

“I was so fortunate to be able to use iTempShield while waiting for a bone marrow transplant. Because of its alert, I knew I needed to get to the hospital for IV antibiotics,” said Thomas Reimer, a Boston-based leukemia patient who participated in early testing of the iTempShield technology. “I literally think iTempShield helped save my life.”

iTempShield is simple to use and fits seamlessly into the healthcare ecosystem. iTempShield’s accompanying remote monitoring platform ensures patients and their clinicians are alerted if their temperature exceeds a set threshold set by a healthcare professional over a given period. AION architected the platform to easily integrate into hospital or physician medical records systems and remote patient monitoring systems. Its unique adhesive is FDA cleared and is appropriate for use across the most sensitive patient populations.

“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.”

AION’s iTempShield is immediately available at scale for the early detection of infection and sepsis. Healthcare providers interested in learning more about the remote monitoring device and platform can contact demo@aionbiosystems.com or visit the company’s website for more information.

“This is a great day for the AION Biosystems team, who in under just two years brought a groundbreaking remote patient monitoring device and platform from concept to regulatory clearance,” said Dr. Peter Costantino, founder and chairman of AION Biosystems. “This milestone represents a significant increase in shareholder value and rewards our investors for the confidence they have shown in the company and its management team.”

About AION Biosystems

AION Biosystems is a medical technology company dedicated to dramatically expanding the use and value of remote patient monitoring through a unique product and cloud-based software platform. Its first FDA-cleared offering is the iTempShield, a low-profile, skin-applied device that measures temperature accurately and continuously for up to 60 days. iTempShield leverages an AI-powered algorithm to maximize accuracy of its readings and improve remote patient monitoring. AION will continue to add more monitoring functionality to its devices over time, with the ultimate goal of delivering an AI platform that will become the standard for predictive health outcomes. For more information, visit aionbiosystems.com.

¹ AION Biosystems data on file.
² Anand Kumar et al. (2006) Duration of hypotension prior to initiation of effective antimicrobial therapy is the critical determinant of survival in human septic shock. Critical Care Medicine.
³Yongqiang Zheng, et al. (2021) Fatal Infections Among Cancer Patients: A Population-Based Study in the United States. Infect Dis Ther.
⁴ Yurii B. Shvetsov et al. (2021) Association of Sepsis Mortality with Specific Cancer Sites and Treatment Type: The Multiethnic Cohort Study. J Pers Med.