AION's iTempShield Skin-Wearable Device and Software Platform Granted FDA Clearance for Professional and Retail Applications

Thursday, August 31, 2023

AION Biosystems, a company at the forefront of medical technology dedicated to expanding remote patient monitoring, has successfully obtained FDA 510(k) clearance for its innovative iTempShield™ device and software system. The iTempShield system, approved for use with adults and children aged five and older, has received the green light for deployment in hospitals, outpatient healthcare facilities, remote patient monitoring setups, as well as for direct over-the-counter sales.

The iTempShield device, compact like a quarter in size, comes accompanied by cloud-based software and proprietary algorithms. This comprehensive platform empowers the continuous tracking of body temperature, offering a range of clinical applications including sepsis monitoring within oncology, detection of post-surgical infections, long-term care supervision, and even personalized home health management. The initial focus of AION Biosystems will be on early infection detection among cancer patients and residents of long-term care facilities.

Distinguished by its discreet design, the low-profile iTempShield adheres gently to the skin's surface on the chest area. Its extended battery life of up to 60 days not only promotes patient adherence but also renders it eligible for device reimbursement under CMS-approved remote patient monitoring CPT codes, thereby providing a consistent revenue stream for healthcare providers while enhancing patient well-being.

Given that an elevated body temperature often signals the onset of infection, particularly the critical condition of sepsis, AION Biosystems has placed an emphasis on achieving unparalleled accuracy compared to other skin-applied devices that have previously gained FDA clearance for medical and consumer usage. The iTempShield achieves an impressive level of precision – being four times more accurate than traditional oral thermometers – thanks to the integration of advanced AI-powered algorithms designed to calculate body temperature.

Presently, iTempShield has already been put into practical use at Ellis Medicine's Roswell Park Cancer Institute and has also been incorporated into an innovative Smart City program in Schenectady.

Dr. Nicholas Montalto, Chief Medical Officer at Ellis Medicine, highlighted the potential of iTempShield to revolutionize infection management, particularly among cancer patients and individuals with compromised immune systems. The device's capability to continuously monitor body temperature allows for the early identification and treatment of infections before they escalate into life-threatening scenarios.

Traditional practices often involve cancer patients taking their oral temperature when they begin to feel unwell, often leading to the identification of infections at an advanced stage. Inaccuracies in measurement methods also contribute to this challenge. However, early detection is pivotal, as delayed administration of antibiotics in sepsis cases substantially increases the risk of mortality. Astonishingly, 60% of cancer-related deaths are attributed to infections, with 9% arising from sepsis.

Real-life experiences like that of Thomas Reimer, a leukemia patient from Boston, underscore the device's potential to influence patient outcomes positively. Reimer shared his story of how iTempShield's alerts prompted him to seek hospital care for IV antibiotics, which ultimately played a significant role in saving his life.

iTempShield's user-friendly design ensures seamless integration into various healthcare systems. The accompanying remote monitoring platform promptly notifies both patients and clinicians should body temperatures exceed thresholds established by healthcare professionals. AION has meticulously developed the platform to facilitate easy integration into medical records and remote patient monitoring systems. The adhesive used is FDA-approved and suitable for even the most sensitive patient populations.

Samara Barend, CEO of AION Biosystems, highlighted the transformative potential of iTempShield in remote patient monitoring, emphasizing its simplicity, accuracy, and cost-effectiveness in contributing to life-saving measures.

AION's iTempShield is available on a large scale immediately, offering the potential for early detection of infections and sepsis. Healthcare providers keen on incorporating this remote monitoring solution can establish contact through the company's website or via email.

Dr. Peter Costantino, Founder and Chairman of AION Biosystems, expressed his pride in achieving rapid progress from concept to regulatory clearance for this groundbreaking remote patient monitoring system. He viewed it as a substantial enhancement of shareholder value and recognition of the management team's dedication and performance.

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