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# Sibel Health Infant Monitor Cleared
- URL: https://www.fdaweb.com/sibel-health-infant-monitor-cleared/
- Published: 2023-05-11T12:00:00.000Z
- Updated: 2026-09-14T18:31:21.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5154427

FDA has cleared a Sibel Health 510(k) on the ANNE One platform for continuous neonatal and infant monitoring for newborns and infants aged up to two years. The device monitors physiological parameters, such as heart rate, respiratory rate, skin temperature, body temperature, apnea-hypopnea index, total sleep time, snoring, chest wall movement, body position, pulse rate, peripheral arterial tonometry, and SpO2\. The company says it is now collaborating with Montreal Children's Hospital and McGill University to jointly create the world’s first wireless neonatal intensive care unit.