FDA Clears Wearable Ring Device that Monitors Sleep Quality and Health Data

The Food and Drug Administration (FDA) has granted 510(k) clearance for the Happy Ring Health Monitoring System (Happy Health, Austin, TX), a ring-shaped device worn on the finger that monitors biometric health data useful for care coordination for sleep apnea and other conditions. The health metrics monitored by the device include sleep quality, blood oxygen level, heart rate, daily activity, body temperature, and brain activity. Happy Health has also announced a planned clinical program for Happy Ring, called Happy Sleep.

Happy Ring comprises sensors for broad-spectrum photoplethysmogram (PPG), continuous electrodermal activity (EDA), skin and ambient temperature, and an accelerometer. According to a statement from the company, Happy Ring can be implemented into Happy Health’s wider platform, which incorporates machine learning (ML) algorithms to equip patients and their caregivers with a clinical context for collected data. Happy Ring transmits data directly to patients and their care teams, facilitating care for sleep apnea, heart disease, and other conditions.

"Combining devices with doctors is critically important," said Dustin Freckleton, MD, CEO of Happy Health. "Healthcare is not monitoring a single biomarker or treating a single condition. We're ensuring patients can receive fully coordinated clinical monitoring of nearly any medical condition, headache-free, so they can focus on their health without the hassle."