A Breakthrough in Wearable Health
Apple has received De Novo clearance from the US Food and Drug Administration for a blood pressure monitoring feature on the Apple Watch Ultra 3. The clearance makes the Ultra 3 the first consumer smartwatch to offer clinical-grade blood pressure readings, a milestone the wearable health industry has been pursuing for over a decade.
How It Works
Unlike traditional blood pressure cuffs that use an inflatable bladder to measure arterial pressure, the Apple Watch Ultra 3 uses a combination of optical sensors and a new piezoelectric pressure sensor array built into the back crystal of the device.
- Pulse transit time: The system measures how quickly pulse waves travel between the wrist arteries, a metric closely correlated with blood pressure.
- Optical plethysmography: Enhanced green and infrared LED sensors track blood volume changes with higher precision than previous Apple Watch generations.
- Calibration: Users must calibrate the system once using a standard arm cuff. The watch then provides continuous estimates between calibrations, with Apple recommending recalibration monthly.
- Accuracy: In clinical trials involving 2,800 participants, the system achieved accuracy within 5 mmHg of cuff-based readings for both systolic and diastolic pressure 92% of the time, meeting FDA requirements.
Clinical Significance
High blood pressure affects approximately 1.3 billion people worldwide and is a leading risk factor for heart disease and stroke. The challenge with hypertension is that it is largely asymptomatic, meaning many people are unaware they have it until a serious cardiac event occurs. Continuous monitoring via a device already worn daily could dramatically improve early detection.
"This is potentially the most significant advancement in hypertension management since the introduction of ACE inhibitors. Continuous, effortless monitoring changes the entire treatment paradigm," said Dr. Manesh Patel, chief of cardiology at Duke University Medical Center.
The Regulatory Path
Apple pursued the De Novo classification pathway, which is used for novel devices that have no existing predicate. The process took approximately 18 months from initial submission to clearance. Apple submitted data from three clinical trials conducted at sites across the United States, Europe, and Asia, encompassing diverse populations in terms of age, ethnicity, and health status.
The clearance comes with specific labeling requirements. Apple must clearly communicate that the feature is intended for general wellness monitoring and is not a substitute for clinical blood pressure measurement in diagnostic settings.
Software Update Timeline
The blood pressure monitoring feature will be enabled via a watchOS update expected within 30 days. Only the Apple Watch Ultra 3, which contains the necessary piezoelectric sensor hardware, will support the feature. Existing Apple Watch models, including the Series 11 and SE, do not have the required sensor array.
Competitive Landscape
Samsung has been pursuing blood pressure monitoring on its Galaxy Watch line, though its implementation requires more frequent calibration and has not yet received FDA clearance for the US market. Google's Pixel Watch team is reportedly working on similar technology for a future release. Withings obtained FDA clearance for its ScanWatch blood pressure feature in 2025, but it uses a different, cuff-like mechanical approach.
Apple's clearance is expected to accelerate the entire category, putting pressure on competitors and further establishing the smartwatch as a legitimate medical monitoring device.
