Oura Ring 5 Faces US FDA Probe Over Heart Data Accuracy Claims, Raising Health Tracking Concerns
Washington D.C. — The United States Food and Drug Administration has initiated an investigation into the Oura Ring 5 wearable device amidst growing allegations of inaccurate heart rate and sleep-stage data reporting, according to an official statement released Wednesday.
What: The FDA is probing the Oura Ring 5’s core biometric sensors, specifically its ability to reliably measure heart rate variability and detect sleep-wake cycles. Preliminary reports indicate the device may misclassify deep sleep stages and exhibit a variance of up to 8% in resting heart rate readings compared to clinical-grade electrocardiogram equipment.
Who: The investigation targets Oura Health Oy, the Finnish manufacturer of the smart ring. The probe involves the FDA’s Center for Devices and Radiological Health, alongside consumer advocacy groups and academic sleep researchers.
When: The investigation was formally launched on Tuesday. The FDA confirmed it will conduct a 90-day review of all public complaint data and proprietary testing results, with a preliminary report expected by the end of the current fiscal quarter.
Where: The probe is centered in the United States, where over 2.5 million Oura Ring 5 units have been sold since its launch in November 2024. Global regulators in the European Union and South Korea are also monitoring the findings.
Why: The inquiry stems from a series of consumer lawsuits and peer-reviewed studies published in the Journal of Medical Internet Research, which highlighted discrepancies in the device’s metabolic tracking algorithms. Investigators are concerned that inaccurate health data could lead to misdiagnoses or improper self-care decisions among users relying on the ring for fertility tracking and athletic recovery.
Oura Health has not yet issued a formal response to the probe, but a company spokesperson stated they are “fully cooperating with regulatory authorities to ensure data integrity.”