Registry/Biometric wearables
Biometric wearables
AI-augmented biometric tracking devices: smart rings, watches, and bands with FDA-clearance verification anchors.
Biometric wearables span smart rings (Oura, RingConn, Ultrahuman, Amazfit Helio), AI-augmented watches (Apple Watch, Google Pixel Watch, Fitbit, Samsung Galaxy Watch, Withings ScanWatch, Garmin), and biometric bands (Whoop). Distinct from AI-primary wearable AI (smart glasses, AI pendants, tracked separately at /wearable-ai): biometric-primary devices treat AI as an inference layer on top of sensor data rather than the primary product surface. FDA clearance is the verification anchor for medical-grade claims (AFib, AHI, SpO2, blood pressure); the verified-vs-claimed asymmetry reads as cleared-by-FDA versus marketed-as-wellness. Whoop's blood-pressure warning letter and Oura's study-first cadence anchor the exemplar pair for this category.
Companies (15)
View all →- Abbott
Abbott Park, Illinois, USA
- Apple
Cupertino, California, USA
- Dexcom
San Diego, California, USA
- Fitbit
San Francisco, California, USA
- Garmin
Olathe, Kansas, USA
- Google
Mountain View, California, USA
- Happy Health
Austin, Texas, USA
- Movano Health
Pleasanton, California, USA
- Oura
Oulu, Finland
- RingConn
Shenzhen, China
- Samsung Electronics
Suwon, South Korea
- Ultrahuman
Bengaluru, India
Models (15)
View all →- Amazfit (Balance / Active / T-Rex / Helio)by Zepp Health (Amazfit)commercial
- Apple Watchby Applecommercial
- Evie Ring (and EvieMED)by Movano Healthcommercial
- Fitbit (Charge / Sense / Versa)by Fitbitcommercial
- Garmin (Venu / Fenix / Forerunner)by Garmincommercial
- Happy Ringby Happy Healthcommercial
- Lingoby Abbottcommercial
- Oura Ring 4by Ouracommercial
- Pixel Watchby Googlecommercial
- RingConn (Gen 2 / Gen 3)by RingConncommercial
- Samsung Galaxy Watch (and Galaxy Ring)by Samsung Electronicscommercial
- Steloby Dexcomcommercial
Regulations (1)
- EU Artificial Intelligence Act (Regulation (EU) 2024/1689)European Union · other
Incidents (9)
- ITC instituted an Oura patent investigation naming the Amazfit Helio Ringregulatory_action · 2025-12-18
- Class action (Rowe v. WHOOP) alleges WHOOP falsely advertised BPI as medical-gradeother · 2025-11-18
- ITC banned Ultrahuman Ring Air US imports/sales for infringing Oura patent 11,868,178regulatory_action · 2025-10-21
- RingConn settled the Oura ITC patent case with a royalty-bearing license (avoided a ban)other · 2025-10-20
- Class action (Lomeli v. WHOOP) alleges health-data sharing without consentother · 2025-08-13
- FDA warning letter to Whoop: Blood Pressure Insights marketed beyond clearanceregulatory_action · 2025-07-14
- Apple disabled Blood Oxygen on US Apple Watch to comply with a Masimo ITC exclusion orderregulatory_action · 2024-01-18
- Withings ScanWatch FDA Class 2 recall: app bug let users run ECG without physician reviewrecall · 2022-12-19
- Fitbit Ionic burn-hazard recall (~1M US units); $12.25M CPSC penalty in 2025recall · 2022-03-02