Garmin (Venu / Fenix / Forerunner) at Global

Garmin (NASDAQ: GRMN; founded 1989 by Gary Burrell and Min Kao) makes biometric-primary multisport watches such as the Venu 3, Fenix 8, and Forerunner 965 with AI augmentation, recorded in the new biometric form factor. Its devices carry optical heart-rate, blood-oxygen, ECG on select models, and skin-temperature sensors, and layer proprietary analytics including Body Battery, Training Load and Training Readiness, advanced sleep tracking with a Sleep Score and coach, all-day stress, and HRV Status.

Its one FDA clearance is the ECG App, cleared via 510(k) K221774 with a decision dated January 12, 2023 and launched on January 24, 2023 on the Venu 2 Plus as Garmin's first FDA-cleared feature for on-demand assessment of signs of atrial fibrillation, later expanded by software to other models. A cap-flag applies because most of Garmin's analytics, including blood oxygen, Body Battery, Training Readiness, stress, and Sleep Score, are wellness features rather than FDA-cleared, with Body Battery in particular a proprietary composite rather than a validated clinical metric, making Garmin lighter on FDA-cleared clinical AI than Apple or Fitbit.

Garmin is the purchase-only outlier of the cohort: all core health and training features are free with no required membership, and the newer Garmin Connect+ subscription launched March 27, 2025 at $6.99 a month is optional, adding AI Active Intelligence insights and coaching content without gating existing features, in contrast to subscription-only Whoop and membership-required Oura. Its clinical-validation posture is lighter on cleared clinical AI with strong sensor hardware but proprietary, largely non-peer-validated recovery and training metrics, and the accuracy of Body Battery and Training Readiness and any 2026-model specifics are not verified.