Sibel Health Received EU MDR Class IIb CE Mark for ANNE® One: The First Wireless Wearable Patient Monitoring Platform Certified to Key Interoperability Standards (Regulatory Update)
On 10 June 2026, Sibel Health Inc., an award-winning medical technology company, announced that its ANNE® One system had received CE Mark certification under the European Union Medical Device Regulation (EU MDR 2017/745) as a Class IIb medical device. The certification came at a critical time for the European healthcare sector, where an aging population and a growing shortage of healthcare professionals were placing significant pressure on care delivery systems. Continuous wireless ...