Financial & Business

Sibel Health Closes Series C Financing, Reveals FDA Clearance

The new 510(k) clearance positions the company for commercial expansion in medical monitoring.

By: Michael Barbella

Managing Editor

The wireless wearable ANNE One platform for vital signs monitoring. Photo: PRNewswire.

Sibel Health has closed $30 million in new equity financing, led by existing investors, the Steele Foundation for Hope and Dräger. The former previously led the company’s Series B round funding, investing an additional $20 million this time, while the latter contributed $10 million.

The money will help the firm commercialize its ANNE One monitoring platform. “Given the very challenging financing environment, we are ecstatic to see our existing investors fund our entire round given their confidence in our product roadmap and growth trajectory,” Sibel Health Co-Founder/CEO Steve Xu M.D., said.

Enabled by advanced clinical-grade wearable sensors, the ANNE One platform offers wireless monitoring of all vital signs for patients 12 years and older. This financing is timed to Sibel’s newest U.S. Food and Drug Administration (FDA) 510(k) clearance that authorizes enabling alarms and alerts along with a powerful central station for the ANNE One platform.

“We are especially proud of the fact that our sensors are FDA-cleared under the IEEE SDC 11073 standard, which supports open and secure communication between medical devices replacing traditional proprietary networks. Interoperability is the future and our hospital partners are increasingly demanding it,” Sibel Health Co-Founder/Chief Technology Officer Jong Yoon Lee stasted. The ANNE One platform is one of the first medical devices to receive FDA-clearance following the IEEE SDC 11073 standard.

“Without interoperability of medical devices, particularly vital signs monitors like ours, we cannot capture the broader care context and realize the full potential of AI to detect patient deterioration earlier,” Dr. Xu added.

In early 2024, Sibel Health was awarded a $17.5 million grant from the Gates Foundation. Later in 2024, Sibel Health and Dräger Denmark was selected by the Capital Region of Denmark to provide continuous wireless monitoring in multiple Copenhagen area hospitals. In March 2025, Sibel Health, a spinout of Northwestern University, announced that Northwestern Medicine acquired ANNE One systems to evaluate improvements to both nursing workflow and patient sleep quality with wireless sensors.

“We are pleased to further strengthen the cooperation between Dräger and Sibel through this investment. The possibility to integrate wireless, wearable sensors into the digital acute care ecosystem via the new connectivity standard ISO/IEEE 11073 SDC is an important milestone towards the future of patient monitoring along the entire patient care journey,” said Sibel board member Toni Schrofner, chief officer, Medical Division, at Dräger.

Based in Chicago with an international office in Seoul, South Korea, Sibel Health provides advanced monitoring solutions for patients of all ages in the home or hospital. In addition, Sibel Health offers digital health technologies for the pharmaceutical and clinical research markets.

Dräger is an international developer of products that protect, support, and save lives. Founded in 1889, Dräger generated revenues of around €3.4 billion in 2024. The Dräger Group is currently present in more than 190 countries and has over 16,000 employees worldwide.

Founded in 2021, the Steele Foundation for Hope strives to find and fund lasting solutions for tough challenges, with a strong belief that advances found through technology and innovation are key to improving quality of life.

Keep Up With Our Content. Subscribe To Medical Product Outsourcing Newsletters