CUPERTINO, Calif. — Apple on Tuesday introduced a new feature for its smartwatch that notifies users who may have high blood pressure, the company’s latest bid to help people stay informed about issues impacting their health with devices they use every day.
Apple has consistently added heart health features to the Apple Watch, including detection of arrhythmias like atrial fibrillation. Because of the device’s wide distribution, it has the potential to catch health conditions in many people who would not otherwise know about them. Critics note that screening a large population for disease will potentially flag many people who do not have conditions, causing anxiety and increasing health care costs.
Sanket Dhruva, a cardiologist at the University of California, San Francisco, said he is “enthusiastic about the possibilities” presented by the new feature. “But I do have some questions,” he said.
“Addressing hypertension is critical,” said Dhruva. “However, it is important to know how accurate the diagnosis of hypertension will be, and when it will take place. There are specific recommendations around assessing blood pressure.” For example, people are meant to be at rest for several minutes before taking their blood pressure.
Apple did not detail the feature in depth, but in an announcement video screened in the Steve Jobs Theater at Apple Park, Apple Vice President of Health Sumbul Desai said the feature works by “analyzing how your blood vessels respond to beats of the heart.” An algorithm works in the background, and the watch notifies users of possible hypertension if it detects patterns of high blood pressure over a 30-day period. Desai said the machine learning models were developed using data from studies totaling over 100,000 people.
Desai conceded the feature “won’t detect all instances of hypertension,” but the company expects to notify over one million people in the first year. The comment suggests the company will err on the side of correctly identifying hypertension rather than catching every single case.
“What is most important here is that we ensure that patients who actually have high blood pressure do not mistakenly get found to have normal blood pressure by the Apple Watch,” said Dhruva. “If that were to happen, it could lead to false reassurance.”
Desai said the company expects clearance from Food and Drug Administration soon, with the feature coming in a software update this month to the Watch Series 9 and later, and Apple Watch Ultra 2 and later.
Rohan Khera, a cardiologist and researcher at Yale University, said the feature could help address a major public health problem that often goes undetected. In particular, he noted an opportunity in younger people who own Apple Watches but don’t often seek medical care.
“I think any technology that enables the identification of those at risk who should get frequent blood pressure checks is good,” said Khera. But he noted that “the only issue is their performance — whether they are going to have too many false positives in the low-risk individuals.”
Apple has been said to be working on the feature for several years. Its planned release comes at a time when blood pressure monitoring is emerging as an important differentiating feature for wearables.
Wearable maker Whoop earlier this year launched a blood pressure feature without seeking FDA clearance. The agency warned the company its feature is a medical device that ought to be regulated; Whoop argued it’s a wellness feature not intended to treat or diagnose a disease.
In July, another wearable maker, Aktiia, received FDA clearance for its blood pressure-focused wearable. That device’s clearance requires frequent calibration, and the company has said it won’t launch it in the United States until 2026, when it expects to receive clearance for a more user-friendly design.
Asked recently whether he was concerned about its intellectual property and Apple’s possible entrance to the market, Aktiia’s co-founder and chief technology officer, Josep Sola, seemed confident in the company’s technology and legal standing.
“Will they manage to get at the same level of accuracy and precision that they will get regulatory approval? Probably they will,” said Sola. “What happens when this happens? Well, then this will be a patent fight.”
Several of the Apple Watch features have been the subject of patent claims by companies who came to market first. Apple was forced to remove blood oxygen tracking from the device after a successful patent claim by medical device maker Masimo. Apple in August released a redesigned version that worked around the embattled technology.
Source link
