Apple will roll out a hypertension detection feature for its smart watches next week after receiving clearance from the US Food and Drug Administration.

The new tool, first announced in September, will be available in 150 countries and regions, including the US, Hong Kong, and the European Union.

It uses the Apple Watch’s optical heart sensor to analyze blood vessel responses to heartbeats over a 30-day period, and notifies users if signs of chronic hypertension are detected.

The feature will be supported on Apple Watch series 9, series 10, series 11, Ultra 2, and Ultra 3.

Hypertension affects about 1.3 billion adults globally, and is a primary risk factor for stroke, heart attack, and kidney disease.

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🔗 Source: Bloomberg

🧠 Food for thought

Implications, context, and why it matters.

FDA regulatory approach creates winners and losers in wearable health space

Apple’s successful FDA clearance for hypertension detection contrasts sharply with WHOOP’s ongoing regulatory battle, highlighting how similar blood pressure monitoring features face different regulatory outcomes. In July 2025, the FDA issued a warning letter to WHOOP over its Blood Pressure Insights feature, classifying it as a medical device requiring pre-market approval despite WHOOP’s arguments that it’s a wellness tool. Apple’s approach involved extensive clinical validation with training data from studies with more than 100,000 participants, demonstrating the level of evidence the FDA expects for approval. The regulatory framework established by the 1976 Medical Device Amendments allows Class II devices like Apple’s feature to use the 510(k) process, which can provide a clearer pathway to market compared to more ambiguous wellness product classifications. This divergent treatment shows how strategic regulatory positioning and robust clinical evidence can determine market access in the rapidly evolving wearable health space.

Wearable health market shows explosive growth despite regulatory complexity

The global fitness tracker market is projected to grow from $60.9 billion in 2024 to $162.8 billion by 2030, representing an 18.0% compound annual growth rate. The U.S. wearable medical devices market specifically is expected to exceed $100 billion by 2033, growing at over 25% annually from its current $11.45 billion valuation. This growth occurs despite regulatory challenges, with Apple’s hypertension feature targeting the 1.3 billion adults worldwide affected by high blood pressure. The market expansion reflects increasing consumer health consciousness and technological capabilities, even as companies navigate complex FDA oversight that can classify similar features differently based on their intended use and clinical validation approach.

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