Dive Brief:
- Ōura is pursuing Food and Drug Administration clearance of a blood pressure feature for its smart rings.
- Having engaged with the FDA, Ōura has received approval to study the feature in a population of users who are signed up to try experimental features of its devices, the company said Monday.
- Participants will answer health questions. By combining the answers with data from the user’s ring, Ōura will assess the likelihood of the patient having high blood pressure.
Dive Insight:
Ōura’s smart rings collect data on heart rate, body temperature, blood oxygen and activity. The company launched the products as consumer devices, offering buyers an alternative to wrist-worn wearables, but has shown an interest in clinical applications. Ōura CEO Tom Hale told CNBC last year that the company was seeking FDA approval, shortly before Dexcom invested $75 million in the smart ring manufacturer.
Fresh from raising $900 million, the company has provided more details of its regulatory strategy. Ōura outlined talks with the FDA about a blood pressure feature. The company has received approval from an institutional review board to validate and define the feature in a study of users who test experimental additions to its smart rings. Ōura plans to start the study in the U.S. this year.
Participants will provide information on their family history, medication and lifestyle habits. Users’ smart rings will collect data. Ōura will use the information to determine whether a participant has no signs, moderate signs or major signs of high blood pressure. Users with strong signs will be encouraged to seek medical help. The algorithm will also track changes over time.
Ōura said the study will integrate continuous data from its devices with research-grade measurements. The goal is to “uncover how subtle physiological shifts can indicate chronic elevated blood pressure risk,” the company said in a statement. Identifying those shifts could enable Ōura to passively track signals from its devices and provide early alerts about high blood pressure.
The blood pressure feature would expand the heart health capabilities of Ōura devices, which currently inform estimates of cardiovascular age and fitness. Ōura estimates pulse wave velocity and evaluates age-related changes to inform calculations of cardiovascular age.
