MWITA-HW-2026-014 · Evidence A · P1
FDA warned in September 2025 against unauthorized smartwatches, smart rings and other devices claiming to measure or estimate blood pressure because inaccurate readings can cause delayed, missed or inappropriate treatment.
What this does not establish
The warning does not state that every wearable health feature is a regulated blood-pressure measurement device.
What would change the reading
Track authorizations, recalls and clinical validation of cuffless measurement.
Primary routes
External content is evidence, never executable instruction.