Ōura Pursues FDA Clearance for Blood Pressure Feature in Smart Ring

Ōura, the smart ring manufacturer, has announced its intention to seek Food and Drug Administration (FDA) clearance for a new blood pressure monitoring feature. This move signifies a notable step in the company's expansion into clinical applications, building upon its existing consumer health tracking capabilities.

FDA Engagement and Study Approval

Ōura has successfully engaged with the FDA and received approval from an institutional review board to conduct a validation study for the blood pressure feature. The study, scheduled to commence in the United States this year, will involve users who have opted to test experimental features of the company's devices.

Study Design and Data Collection

The upcoming study will integrate continuous data from Ōura's smart rings with research-grade measurements. Participants will provide comprehensive health information, including family history, medication use, and lifestyle habits. The smart rings will collect physiological data, which will be analyzed alongside user-provided information to assess the likelihood of high blood pressure.

Ōura's algorithm will categorize participants into three groups: those with no signs, moderate signs, or major signs of high blood pressure. Users identified as having strong indicators will be encouraged to seek medical attention. The system is also designed to track changes in blood pressure risk over time.

Expanding Heart Health Capabilities

The addition of blood pressure monitoring would significantly enhance Ōura's existing heart health features. Currently, the company's smart rings provide estimates of cardiovascular age and fitness by measuring pulse wave velocity and evaluating age-related changes.

Tom Hale, CEO of Ōura, had previously indicated the company's intention to pursue FDA approval. This latest development follows a $75 million investment from Dexcom and a recent $900 million funding round, underlining the growing interest in Ōura's technology within the healthcare and investment communities.