AION Biosystems, Inc.

AION Biosystems develops and commercializes the AION TempShield™, an FDA-cleared Class II medical device for continuous, non-invasive body temperature monitoring. The TempShield is a wearable sensor designed for 24/7 real-time tracking with up to 90 days of battery life per charge. The device features Bluetooth connectivity, mobile app integration, and seamless electronic medical record (EMR) integration, supported by a dedicated clinician dashboard. Reimbursable under CMS code 99454, the TempShield targets early detection of infection-related complications across multiple clinical settings: oncology (60% of cancer deaths are infection-related), post-operative care (23.7% of surgical patients experience postoperative fever), pediatrics (75,000 children develop sepsis annually in the U.S.), long-term care facilities, and general sepsis management. The device addresses a critical care gap by enabling earlier identification of infection before progression to severe sepsis or organ failure, potentially reducing hospitalizations, readmissions, and associated healthcare costs. Clinical evidence cited on the company website demonstrates that each hour of delay in antibiotic administration for sepsis increases mortality risk by 7.6%, making early detection instrumental to patient outcomes. Manufacturing and regulatory capabilities include FDA 510(k) clearance and integration with major health information systems.