Apple Watch Gets FDA Clearance for Hypertension Monitoring

FDA clearance of Apple Watch hypertension feature enables scalable RPM, aiding patients and providers in early detection.

Apple has received clearance from the US Food and Drug Administration (FDA) for a new Apple Watch feature that monitors hypertension risk, a move experts say could transform remote patient monitoring (RPM) ().

The milestone underscores the rising influence of consumer wearables in mainstream healthcare, according to GlobalData.

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TOP INSIGHT

Apple Watch's #FDA clearance for #hypertension monitoring is a major leap forward for remote patient monitoring. This new feature could empower millions to better manage their health and a new era of proactive, preventative care. #AppleWatch #DigitalHealth #RPM

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The feature, soon to be available on Apple Watch Series 9, 10, 11, and Ultra 2 and 3 models, uses an optical heart sensor to track vascular responses across a 30-day period. Unlike single, point-in-time readings, the watch’s continuous monitoring offers more precise insights into hypertension risk—an urgent need, with nearly half of US adults affected by the condition. Apple confirmed the rollout will extend to more than 150 countries in the coming months.

“Hypertension often develops silently but can lead to severe outcomes such as stroke, heart disease, or kidney failure,” said Alexandra Murdoch, Senior Medical Analyst at GlobalData.

“Being able to monitor vascular health continuously from the wrist represents a breakthrough for both patients and healthcare professionals. The FDA’s decision signals that connected devices are no longer peripheral to care delivery—they are now central.”

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The RPM market has grown rapidly as health systems seek to cut costs, improve patient engagement, and manage chronic conditions outside hospital settings. GlobalData projects the market will reach $13.6 billion by 2033, expanding at a 1.1% CAGR, reflecting both its maturity and long-term importance.

Wearables Gain New Credibility as Apple Watch Enters Healthcare Mainstream

While consumer wearables have long featured fitness and heart-rate tracking, FDA clearance elevates the Apple Watch to a new level of clinical credibility. Healthcare providers, particularly in cardiology and primary care, may now view the device as a reliable tool for continuous monitoring and early intervention.

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“The approval comes at a critical moment for US healthcare,” Murdoch added. “Rising hypertension and cardiovascular disease rates are straining providers. This feature gives patients actionable feedback without specialized equipment, while clinicians gain real-time data streams that can detect warning signs before complications develop.”

With this clearance, the Apple Watch is set to play an expanded role in how healthcare systems worldwide address chronic disease, marking a significant step toward integrating consumer technology into clinical practice.

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