Sibel Health’s ANNE One platform secures EU MDR CE mark

Sibel Health has received CE mark certification under the EU MDR for its ANNE One system, designating it as a Class IIb medical device. ANNE One captures ECG, heart rate, respiratory rate, SpO₂, pulse rate, skin temperature, body position, activity, and falls. ANNE One includes ANNE View and a central dashboard, supporting surveillance, notifying clinicians when readings exceed user thresholds. Credit: Sibel Health / PRNewswire. Sibel Health has received CE mark certification under the EU Medical Device Regulation (EU MDR 2017/745) for its ANNE One system, designating it as a Class IIb medical device. ANNE One is designed to provide…

Source: Medical Device Network