Sibel Health, a spinout of Northwestern University, has received the US Food and Drug Administration (FDA) 510(k) clearance for its ANNE One monitoring platform.
The FDA approval includes alarms and alerts, alongside a central station, and makes ANNE One align with the IEEE SDC 11073 standard.
In addition to the approval, the company has secured $30m in new equity financing, led by existing investors Steele Foundation for Hope and Dräger
Steele, which previously led Sibel’s Series B round, contributed an additional $20m, while medical and safety technology firm Dräger added $10m to its previous Series A investment.
Sibel Health co-founder and CEO Steve Xu said: “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.
“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.”
Sibel plans to use the funding to deploy its platform, which features advanced wearable sensors for wireless monitoring of vital signs in patients aged 12 and older.
In early 2024, Sibel Health received a $17.5m grant from the Gates Foundation.
The same year, Sibel and Dräger were selected by the Capital Region of Denmark to provide continuous wireless monitoring in multiple hospitals in the Copenhagen area.
Recently, Sibel announced that Northwestern Medicine had acquired ANNE One systems to evaluate improvements in nursing workflow and patient sleep quality using wireless sensors.
Dräger medical division chief officer and Sibel board member Toni Schrofner said: “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.”
