Wearable Smart Ring Receives FDA Clearance for Noninvasive Blood Oxygen Monitoring

Wearable form factors increasingly integrate sensors that measure this parameter non-invasively. As interest grows in reliable oxygen saturation measurements beyond traditional settings, options reviewed by regulators are expanding. 

The RingConn Smart Ring (Shenzhen Ninenovo Technology Limited; Shenzhen, China) has received U.S. Food and Drug Administration (FDA) 510(k) clearance for non-invasive SpO2 measurement. The company describes the clearance as a milestone within the FDA‑cleared wearable health device category. The determination affirms that the device is substantially equivalent to legally marketed predicate devices for non-invasive SpO2 assessment.

The ring achieves blood oxygen measurement using photoplethysmography (PPG) sensor technology alongside other embedded advancements. By integrating this capability into a finger-worn format, the system concentrates optical sensing at a site commonly used for pulse oximetry. The platform is positioned to deliver professional‑grade monitoring features within an everyday wearable form factor.

Regulatory review concluded with a finding of substantial equivalence for non-invasive SpO2 measurement, placing the device within an established pathway for such technologies. The clearance supports compliance for RingConn’s expansion into the U.S. healthcare and wellness market, according to the announcement. It also strengthens the technical foundation for health monitoring applications built around smart rings.

RingConn reports ongoing clinical research related to blood oxygen monitoring to build a data foundation for clinical validation of the product. The company also cites multiple international certifications achieved to date, including EU CE, U.S. FCC, Japan MIC, UK UKCA, and Australia RCM. The product is stated to be available in more than 190 countries and regions worldwide.

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