Class IIb certification and SDC interoperability bring traditional patient-monitor to a wireless, wearable form factor

CHICAGO, June 10, 2026 /PRNewswire/ — Sibel Health Inc., an award-winning medical technology company, today announced that its ANNE^® One system has received CE Mark certification under the European Union Medical Device Regulation (EU MDR 2017/745) as a Class IIb medical device. ANNE^® One arrives at a pivotal moment for European healthcare. 22% of the EU population is 65 or older. At the same time, the European Commission estimates a shortage of approximately 1.2 million doctors, nurses, and midwives across the EU. Nurses, in particular, face mounting caseloads, longer shifts, and rising burnout. Continuous wireless monitoring with smart alarming represents a workforce multiplier that allows nurses to safely cover more patients, intervene earlier on deterioration, and spend less time on manual spot-checks across hospital wards, step-down units, and hospital-at-home programs.

As a Class IIb device, ANNE^® One delivers continuous, multi-parameter monitoring (ECG, heart rate, respiratory rate, SpO₂, pulse rate, skin temperature, body position, activity, and fall detection) together with the ANNE^® View bedside application and central dashboard for multi-patient surveillance, both capable of notifying healthcare professionals when physiologic data fall outside clinician-selected thresholds. The result is a patient-friendly, skin-mounted, wireless platform with the clinical capability of traditional patient monitors and the safety architecture clinicians and hospital systems require for acute, subacute, and home healthcare environments.

“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,” said Steve Xu, MD, CEO and Co-Founder of Sibel Health. EU MDR is widely regarded as one of the most rigorous medical device regulatory frameworks in the world. “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 organization for reaching this bar,” said Kevin Dwyer, Director of Quality Assurance and Regulatory Affairs at Sibel Health.

In addition, ANNE^® One is the first wireless wearable monitoring platform certified to the IEEE 11073 Service-Oriented Device Connectivity (SDC) family of standards. The solution is designed to communicate natively with other SDC-compatible devices and hospital IT systems, without proprietary gateways or vendor lock-in. Dräger, a global leader in medical and safety technology and a founding contributor to the IEEE 11073 SDC standard through OR.NET, is partnered with Sibel Health to bring ANNE^® One to hospitals across Europe. “Sibel’s decision to build ANNE^® One on the SDC standard reflects exactly the kind of open, interoperable approach to patient monitoring that Dräger has long championed,” said Dr. Jakob Kleissl, President BU Patient Monitoring / System & Interoperability Development at Drägerwerk AG & Co. KGaA. Announced previously, the Capital Region of Denmark selected Sibel and Dräger to co-develop a solution based off of ANNE^® One across Copenhagen area hospitals to support nurses in the general medical and surgical wards.

About Sibel Health
Sibel Health is an award-winning digital health company with a mission to deliver Better Health Data for All^®. Based in Chicago with an international office in Seoul, the company’s FDA-cleared ANNE^® platform includes advanced wearable sensors, AI-enabled data analytics, and an integrated mobile software and cloud platform. The company’s Discovery platform is used by the world’s leading pharmaceutical companies for clinical trials. For more information, visit www.sibelhealth.com, follow us on LinkedIn.

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SOURCE Sibel Health