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 continuous, multi-parameter monitoring for patients in acute, subacute, and home healthcare environments.
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The platform captures metrics such as ECG, heart rate, respiratory rate, blood oxygen saturation (SpO₂), pulse rate, skin temperature, body position, activity, and fall detection.
It includes the ANNE View bedside application and a central dashboard to support multi-patient surveillance, notifying clinicians when readings fall outside of user-selected thresholds.
The CE mark comes at a time when healthcare systems across the EU face significant workforce pressures, according to Sibel Health.
Data from the European Commission (EC) estimated a shortage of approximately 1.2 million doctors, nurses, and midwives, as well as demographic trends that indicate an ageing population.
The company said that technologies supporting wireless monitoring and smart alarm systems could help staff manage larger caseloads across various care settings.
Sibel Health CEO and co-founder Steve Xu said: “From day one, our mission has been to bring high-quality continuous monitoring to every patient, everywhere — whether that’s a maternal patient in the Global South, a postoperative patient in Chicago, or a hospital ward in Copenhagen.”
Sibel Health quality assurance and regulatory affairs director Kevin Dwyer said: “A Class IIb device requires deep scrutiny across design, clinical performance, post-market surveillance, and quality management systems from our notifying body. I am proud of our entire organisation for reaching this bar.”
ANNE One is said to be the first wireless wearable patient monitoring platform certified to the Institute of Electrical and Electronics Engineers (IEEE) 11073 Service-Oriented Device Connectivity (SDC) family of standards, enabling native communication with SDC-compatible devices and hospital IT systems.
The platform does not require proprietary gateways or vendor-specific integration.
Sibel Health is working with Dräger, a medical and safety technology company involved in developing the IEEE 11073 SDC standard, to introduce ANNE One in European hospitals.
The system is being co-developed for use in hospitals in the Copenhagen area under a previously announced collaboration with the Capital Region of Denmark.
