Registry/Biometric wearables
Category
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 (17)
View all →Featured by funding.
- Butterfly Network
Burlington, MA, USA · $1.0B
- Oura
Oulu, Finland · $900M
- Happy Health
Austin, Texas, USA · $60M
- Dexcom
San Diego, California, USA · $50M
- Withings
Issy-les-Moulineaux, France · $30M
- Movano Health
Pleasanton, California, USA · $24M
- Abbott
Abbott Park, IL
- Apple
Cupertino, California, USA
- Circular
Paris, France
- Fitbit
San Francisco, California, USA
- Garmin
Olathe, KS
- Google
Mountain View, California, USA
Models (19)
View all →- Amazfit (Balance / Active / T-Rex / Helio)by Zepp Health (Amazfit)commercial
- Apple Watchby Applecommercial
- Butterfly AI Ultrasoundby Butterfly Networkcommercial
- Butterfly iQ+by Butterfly Networkcommercial
- Circular Ring 2by Circularcommercial
- 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
Verified deployments (14)
View all →- Ultrahuman Ring (Air / Pro) at Globalby (unspecified)operational
- Withings ScanWatch at Globalby (unspecified)operational
- Whoop (5.0 / MG) at Globalby (unspecified)operational
- Oura Ring 4 at Globalby (unspecified)operational
- Fitbit (Charge / Sense / Versa) at Globalby (unspecified)operational
- Garmin (Venu / Fenix / Forerunner) at Globalby (unspecified)operational
- Samsung Galaxy Watch (and Galaxy Ring) at Globalby (unspecified)operational
- Apple Watch at Globalby (unspecified)operational
- Stelo at Globalby (unspecified)operational2024-05-01
- Lingo at Globalby (unspecified)operational2024-05-01
- Butterfly iQ+ at South Africaby (unspecified)operational2023-01-01
- Evie Ring (and EvieMED) at United Statesby (unspecified)operational2023-01-01
Regulations (13)
View all →- ANSI/CAN/UL 3300:2024 - Safety for service, communication, information, education and entertainment (SCIEE) robotsUnited States · safety standard
- ISO 10218-2:2025 - Robotics - Safety requirements - Part 2: Industrial robot applications and cellsGlobal · safety standard
- ISO 10218-1:2025 - Robotics - Safety requirements - Part 1: Industrial robotsGlobal · safety standard
- EU Artificial Intelligence Act (Regulation (EU) 2024/1689)European Union · other
- ISO 18497:2024 - Safety of partially automated, semi-autonomous and autonomous agricultural machineryGlobal · safety standard
- ISO/TR 23482-1:2020 - Robotics - Application of ISO 13482 - Part 1: Safety-related test methodsGlobal · safety standard
- ANSI/A3 R15.08 - Industrial mobile robot (IMR) safetyUnited States · safety standard
- ISO 3691-4 - Industrial trucks - Safety requirements - Part 4: Driverless industrial trucks (AMRs)Global · safety standard
- IEC 60335-2-107:2017 - Safety of robotic battery-powered electrical lawnmowersGlobal · safety standard
- ISO/TS 15066:2016 - Robots and robotic devices - Collaborative robotsGlobal · safety standard
- ISO 13482:2014 - Robots and robotic devices - Safety requirements for personal care robotsGlobal · safety standard
- ANSI/RIA R15.06 - US industrial robot and robot-system safety (adoption of ISO 10218)United States · safety standard
Incidents (10)
- 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
- FDA Class 2 recall of Butterfly iQ Auto Bladder Volume Tool for lacking 510(k) clearancerecall · 2020-02-24
Biometric wearables on the deployment map
Where biometric wearables are verified operating, plotted from sourced deployment records. Explore by place:
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