Will the number of active, non-hospital, non-fitness consumer devices utilizing FDA-cleared ECG technology exceed 50 million globally before 2027?

ECG Goes Mass Market: 50 Million Consumer Devices by 2027

ECG (Electrocardiogram) technology, historically restricted to hospitals, has been integrated into mass-market consumer devices, notably smartwatches. This prediction is that the cumulative number of active, non-hospital, non-fitness consumer devices globally utilizing FDA-cleared (or equivalent regulatory-cleared) ECG technology will exceed 50 million before the end of 2027.

Regulatory Validation Drives Adoption

The 'FDA-cleared' distinction is crucial, transforming the feature from a mere wellness tracker to a validated medical tool capable of detecting conditions like atrial fibrillation (AFib). This regulatory validation builds consumer trust and allows the technology to be integrated into official healthcare pathways.

The growth is driven by the continued expansion of the smartwatch and smart ring markets, particularly by companies like Apple, Samsung, and Google/Fitbit, all of whom are vying to make their devices essential health monitors. With hundreds of millions of smartwatches already sold, and the increasing focus on preventative cardiology, the 50 million active device milestone by 2027 is highly achievable, solidifying wearables as a key tool in digital health.