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# Aion Bio Temperature Monitor Cleared
- URL: https://www.fdaweb.com/aion-bio-temperature-monitor-cleared/
- Published: 2023-08-30T12:00:00.000Z
- Updated: 2026-09-14T18:53:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155216

FDA has cleared an Aion Biosystems 510 (k) for its iTempShield device and software system for continuous measurement of body temperature. The quarter-sized, skin-wearable device is supported by cloud-based software and proprietary algorithms to measure body temperatures for several clinical applications, such as oncology sepsis monitoring, post-surgical infection detection, and long-term care monitoring, according to the company. The monitor can function without recharging for up to 60 days to aid patient compliance, it says, adding that the device is also four times more accurate than an oral thermometer due to “calculating body temperature using a sophisticated library of AI-powered algorithms.”