Samsung Rolls Out Galaxy Watch Blood Pressure Tool in U.S. Without FDA Approval

Overview

• Samsung, which confirmed the U.S. rollout on Monday, said the Galaxy Watch blood pressure tool is not FDA‑approved and is meant for wellness use only.
• Users are warned not to use watch readings for diagnosis or treatment and not to replace a medical‑grade blood pressure monitor.
• The feature tracks blood pressure trends over time to flag patterns that may prompt a doctor visit rather than provide clinical measurements for care decisions.
• Setup requires calibrating the watch with an upper‑arm cuff, with recalibration every 28 days, and works on Galaxy Watch 4 or newer models.
• Apple’s approach differs, with FDA‑cleared Hypertension Alerts from 2025 that notify users of possible high blood pressure patterns without giving actual blood pressure readings.