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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. 

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Update: FDA confirms recalls for defibrillation leads after nearly 400 injuries

Safety concerns with certain Boston Scientific leads has resulted in multiple Class I recalls, the FDA has announced. The agency first shared a warning about this issue in August. 

AI for opportunistic osteoporosis screening inks FDA clearance

The tool analyzes routine hip and pelvis X-rays for signs of low bone mineral density.

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Radiology groups voice ‘enthusiastic support’ for proposal to add 14,000 more Medicare-funded residency slots

The Society of Interventional Radiology and American College of Radiology are thanking lawmakers for reintroducing the Resident Physician Shortage Reduction Act. 

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Radiology providers missing the mark when screening disabled women for breast cancer

Only 43% of women with disabilities receive American Society of Breast Surgeons-recommended mammography screening services, according to a new single-center study. 

Strategic Radiology
Strategic Radiology expands into Colorado, adding decades-old independent imaging group

Colorado Springs Radiologists and its roughly 25 physicians are seeking to gain the benefits of scale without the challenges of consolidation. 

The Dexcom G7 Continuous Glucose Monitoring System
Dexcom issues new recall for CGM apps due to safety risk—users urged to update immediately

The FDA has categorized this as a Class I recall. If patients update their phone or watch apps as needed, they can continue to use these devices like normal.

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Cardiologist sues hospital after he was allegedly let go for sharing safety concerns

The veteran interventional cardiologist claims he was pushed out after repeatedly asking for more coverage from cardiothoracic surgeons in addition to other improvements. The hospital, meanwhile, described the lawsuit as a “collection of false allegations."

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."

Video interview with Wael Jaber, MD, chair of the 2025 American Society of Nuclear Cardiology (ASNC) annual meeting, director of nuclear cardiology and a professor of medicine at Cleveland Clinic, shares some of the key highlights from the conference.
Key trends in nuclear cardiology take center stage at ASNC 2025

Wael Jaber, MD, chair of the 2025 American Society of Nuclear Cardiology annual meeting, shared some key takeaways from the conference. “This is no longer just about imaging for coronary disease," he explained. "Nuclear cardiology now helps guide therapy across a wide range of conditions."

Cardiologists have developed an open-source artificial intelligence (AI) model capable of accurately evaluating a long list of measurements on echocardiography results. The group detailed the development and validation of that model in the Journal of the American College of Cardiology.
Open-source AI model delivers accurate echocardiography assessments

The algorithm, trained on more than 150,000 TTE studies, can calculate 18 different measurements regularly used in echocardiography

Lantheus misled investors about blockbuster imaging agent, class action lawsuit claims

Plaintiff attorneys claim the Massachusetts-based company shattered the competitive position of Pylarify, a PET imaging agent for prostate cancer. 

Around the web

Cardiovascular Business
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. 

Cardiovascular Business
Update: FDA confirms recalls for defibrillation leads after nearly 400 injuries

Safety concerns with certain Boston Scientific leads has resulted in multiple Class I recalls, the FDA has announced. The agency first shared a warning about this issue in August. 

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