How continuous wearable metrics translate into validated clinical surrogate endpoints for heart failure and chronic obstructive pulmonary disease.
While consumer fitness trackers focus on step counts and sleep stages, medical-grade wearables capture calibrated metrics: nocturnal SpO2 dip rate, heart rate recovery slope, and thoracic fluid accumulation.
By tracking gradual changes in nocturnal heart rate, respiration, and impedance-measured thoracic fluid over 14-day rolling windows, clinical algorithms predict congestive heart failure decompensation 2 to 3 weeks before hospitalization.
Gaining regulatory clearance requires clinical trials proving substantial equivalence or clinical efficacy against existing hospital standards, accompanied by detailed human factors testing.