Apple Watch Series 11 Gains FDA Clearance for Hypertension Alerts
Key Points
- Apple Watch Series 11 receives FDA clearance for hypertension alerts.
- Feature uses optical heart sensor and machine‑learning trained on over 100,000 participants.
- Monitors users for a month‑long period to identify patterns indicating high blood pressure.
- Hypertension affects over a billion people worldwide.
- Rollout planned for 150 countries with the Series 11 and Ultra Watch 3 launch on September 19.
- Adds to Apple’s health suite that includes hearing‑aid and sleep‑apnea detection functions.
- Apple faces a lawsuit over its blood‑oxygen monitoring feature.
- Clarification: the regulatory status is FDA clearance, not full approval.
Apple announced that its new Watch Series 11 has received FDA clearance for a hypertension alert feature. The function, unveiled at an Apple event and confirmed by Bloomberg and Apple, uses the watch's optical heart sensor and a machine‑learning algorithm trained on a study of more than 100,000 participants. It monitors users in the background for a month‑long period to identify patterns that may indicate high blood pressure, a condition that affects over a billion people. Apple plans to roll out the feature in 150 countries when the Series 11 and Ultra Watch 3 begin shipping on September 19, adding to its growing portfolio of health‑focused capabilities.
FDA Clearance for Hypertension Alerts
Apple disclosed that the Apple Watch Series 11 has secured FDA clearance for a new hypertension alert feature. The announcement followed an Apple event that highlighted health testimonials from existing watch users. Bloomberg and Apple both confirmed that the clearance has now been granted, moving the feature from a pending status to an authorized health tool.
Understanding Hypertension Alerts
Hypertension alerts aim to detect hypertension, commonly known as high blood pressure, a potentially dangerous condition that affects over a billion people worldwide. Rather than delivering a specific blood‑pressure reading, the feature alerts users when it identifies patterns that suggest a risk of hypertension.
How the Feature Works
The functionality relies on the Apple Watch’s optical heart sensor combined with a new machine‑learning algorithm. This algorithm draws from a study involving more than 100,000 participants to recognize signs of high blood pressure. The watch operates in the background for a month‑long period, continuously seeking patterns associated with hypertension. When the system flags a possible danger, it notifies the wearer, prompting them to seek further medical evaluation.
Global Availability and Launch Timeline
Apple indicated that the hypertension alerts will be available to users in 150 countries. The rollout is tied to the shipment of the Apple Watch Series 11 and the Ultra Watch 3, which are scheduled to begin shipping on September 19.
Apple’s Expanding Health Portfolio
The clearance adds to Apple’s expanding suite of health‑focused features. Last year, Apple received FDA clearance for an over‑the‑counter hearing‑aid function that enables second‑generation AirPods Pro to serve as hearing aids for people with mild‑to‑moderate hearing loss. More recently, Apple also secured clearance for a sleep‑apnea detection capability. These additions reflect Apple’s broader strategy to position its wearable devices as comprehensive health monitoring tools.
Legal Context and Ongoing Challenges
While Apple celebrates new health clearances, the company is also contending with legal challenges. It is currently facing a lawsuit concerning the Apple Watch’s redesigned blood‑oxygen monitoring feature. This litigation underscores the regulatory and legal complexities that accompany the introduction of advanced health sensors in consumer wearables.
Clarification on Regulatory Status
A correction issued on September 15 clarified that the Apple Watch received FDA clearance—not FDA approval—for the hypertension alerts feature. The distinction emphasizes that clearance represents a lower level of authorization compared to full FDA approval.