Expanded Indication Includes Adolescents, Ambulatory ECG, Continuous SpO2, and Non-Invasive Blood Pressure in the Home or Hospital Setting.
CHICAGO, Feb. 7, 2024 /PRNewswire/ — Sibel Health, a leading digital health company, announced today that its continuous wearable monitoring solution, ANNE® One, has received another 510(k) clearance from the U.S. Food and Drug Administration (FDA). The ANNE® One platform now allows for continuous ambulatory ECG monitoring, SpO2, temperature, and non-invasive blood pressure measurements. In addition, this new clearance extends the population to include individuals 12 years and above for monitoring in the home and hospital settings.