Hypertension

High blood pressure increases a patient's risk of heart attack, stroke and other diseases. Most people with hypertension have no symptoms. The Centers for Disease Control and Prevention (CDC) says nearly half of U.S. adults have hypertension, or high blood pressure, and only about 1 in 4 of those individuals has their hypertension under control. The World Health Organization (WHO) expects the epidemic of hypertension world-wide will exceed 1.56 billion people by 2025. Major efforts are underway to better control this primary risk factor through screenings, medication and invasive procedures such as renal denervation in severely uncontrolled patients.

blood pressure hypertension cuff

FDA highlights risks of evaluating blood pressure with unauthorized medical devices

The agency emphasized that many over-the-counter technologies marketed for this purpose have not been properly evaluated. 

The U.S. Food and Drug Administration (FDA) cleared a smart watch artificial intelligence (AI) algorithm that tells wearers if they are suspected of having hypertension, which is expected to help notify about 1 million users over the next year. This a is a new feature of the newly launched Apple Watch Ultra 3, which the company unveiled Sept. 9. Apple gained FDA for its Cardiovascular Machine Learning-Based Notification Software Hypertension Notification Feature (HTNF) Sept. 11, 2025.

FDA clears Apple Watch algorithm for detecting hypertension

The FDA’s decision arrived just days after Apple announced the new feature. "This tool empowers patients and clinicians to work together, putting prevention at the center of care," one cardiologist told Cardiovascular Business. 

The new Apple Watch Ultra 3 offers a groundbreaking hypertension notifications alert users if signs of hypertension are detected using data from its optical heart sensor to analyze how a user’s blood vessels respond to heart beats. The algorithm works passively in the background, reviewing data over 30-day periods, and will notify users if it detects consistent signs of hypertension.

New Apple Watch Ultra 3 makes early hypertension detection a priority

"This tool empowers patients and clinicians to work together, putting prevention at the center of care," said Ami B. Bhatt, MD, ACC chief innovation officer. "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."

Medtronic Symplicity Spyral renal denervation

Medtronic’s RDN system approved in Japan

Hypertension is a significant issue in Japan, impacting an estimated 43 million adults. Medtronic's Symplicity Spyral RDN system is now approved for the treatment of those patients. 

Recor Medical's Paradise Ultrasound Renal Denervation System

Recor Medical gains historic approval for its ultrasound RDN system

Recor Medical's Paradise Ultrasound Renal Denervation System is the first medical device approved for the treatment of hypertension in Japan. It first gained FDA approval back in 2023.

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FDA clears new trial of first-in-class treatment for pulmonary arterial hypertension

The new drug, VTB-10, previously received the FDA's orphan drug designation in 2024.

cardiologist doctor physician patient black diverse hypertension

New hypertension guidelines embrace early treatment, updated risk assessments and renal denervation

New ACC/AHA recommendations encourage clinicians to take a proactive approach when managing patients with elevated or high blood pressure. The inclusion of renal denervation in this document represents clear progress for a relatively new technology.

Wildfire pollution image. Photo courtesy of the American Heart Association.

Air purifiers may reduce cardiovascular risks from pollution and wildfires

Multiple studies in recent years have linked poor air quality to significant cardiac risks. Air filters, however, have shown potential to help combat these risks.