FDA clears Apple Watch algorithm for detecting hypertension
The U.S. Food and Drug Administration (FDA) has cleared a smartwatch artificial intelligence (AI) algorithm that tells users if they show early signs of developing hypertension. The technology is expected to help notify about 1 million individuals over the next year alone. The advanced algorithm is a new feature available on the Apple Watch Ultra 3, which the company unveiled on Sept. 9. Apple gained FDA clearance for its Cardiovascular Machine Learning-Based Notification Software Hypertension Notification Feature (HTNF) just days later on Sept. 11.
The groundbreaking new feature will enable users to monitor for hypertension risk remotely. While it does not use a blood pressure cuff measurement, the gold-standard for hypertension detection and monitoring, the technology does offer wearers a "red flag health alert" that they should see a doctor or test their blood pressure with a cuff. The watch technology uses its optical heart sensor to measure vascular responses over a 30-day period. The long-term monitoring capability provides more accurate insights into the risk of developing hypertension, a chronic condition affecting almost half of U.S. adults.
The function will be available on Apple Watch Series 9, 10, 11, and Ultra 2 and 3 models, and will soon be rolled out in over 150 countries.
“Hypertension typically develops without obvious symptoms and can lead to heart disease, stroke and kidney failure if left untreated. The ability to continuously monitor blood vessel health from the wrist is a breakthrough for patients and healthcare professionals. The FDA’s decision reflects a growing recognition that connected devices are no longer peripheral to healthcare delivery, they are central to it. This validation paves the way for broader adoption of wearables as trusted tools in patient monitoring,” explained Alexandra Murdoch, MHIS, senior medical analyst at GlobalData, a healthcare market data and analysis company.
The company said in a statement this marks a major step forward for wearable health and highlights the growing role of consumer devices in transforming remote patient monitoring (RPM). The RPM market has become an integral part of the healthcare paradigm for patients globally, and it will continue to grow significantly.
"The RPM market has grown rapidly in recent years as healthcare systems look for ways to reduce costs, increase patient engagement, and manage chronic diseases outside of hospital walls,” Murdoch explained.
The FDA said the notifications provided by this new technology are intended to help guide the patient to further testing; they are not meant to be treated as final diagnostic tests. Even with this in mind, however, the technology is expected to deliver considerable value.
"This tool empowers patients and clinicians to work together, putting prevention at the center of care. By incorporating real-world data into clinic visits, clinicians can have a more holistic understanding of a patient's cardiovascular risk. What we really want to do is create patient agency and reach as many people as we can for earlier detection of high blood pressure," explained Ami B. Bhatt MD, chief innovation officer of the American College of Cardiology (ACC) and chair of the FDA Digital Health Advisory Committee, in an interview with Cardiovascular Business when the Apple Watch Ultra 3 was first unveiled.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]