Ōura Pursues FDA Clearance for Blood Pressure Feature in Smart Ring

Ōura, a prominent player in the wearable technology market, has announced its intention to seek Food and Drug Administration (FDA) clearance for a blood pressure monitoring feature in its smart rings. This move marks a significant step in the company's journey from consumer devices to clinical applications, potentially revolutionizing personal health monitoring.

FDA Engagement and Study Approval

Ōura has successfully engaged with the FDA and received approval from an institutional review board to conduct a study validating and defining 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.

Participants will provide comprehensive health information, including family history, medication use, and lifestyle habits. This data will be combined with measurements from the smart rings to assess the likelihood of high blood pressure in users.

Technical Innovations in Blood Pressure Monitoring

The proposed blood pressure feature aims to leverage the continuous data collected by Ōura's devices, integrating it with research-grade measurements. The company's goal is to identify subtle physiological shifts that may indicate chronic elevated blood pressure risk, potentially enabling passive tracking and early alerts for hypertension.

Ōura's smart rings currently collect data on various health metrics, including heart rate, body temperature, blood oxygen levels, and activity. The addition of blood pressure monitoring would significantly expand the device's cardiovascular health capabilities, complementing existing features such as cardiovascular age estimation and fitness evaluation.

Strategic Investments and Market Positioning

This regulatory pursuit follows a series of strategic moves by Ōura. The company recently secured $900 million in funding, positioning itself for expansion and innovation. Additionally, Ōura received a $75 million investment from Dexcom, a leader in continuous glucose monitoring systems, indicating growing interest in the potential of smart ring technology for health monitoring.

As Ōura advances its clinical aspirations, the company is poised to offer a unique alternative to traditional wrist-worn wearables, potentially capturing a significant share of the burgeoning health tech market.