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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.

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.

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.

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 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.

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."

Video of SNMMI President Cathy Cutler explaining advocacy efforts for nuclear imaging. #SNMMI

Policy reforms in Washington that will impact nuclear imaging

SNMMI President Cathy Cutler, PhD, explains some of the key policy initiatives the society is pursuing to help support the field of nuclear medicine.

Can large language models break language barriers in radiology reports?

With the growing demand for virtual care and an increasingly mobile population, the need to improve communication with non-English-speaking patients is immense.

FDA announces recall of cryoablation catheters after multiple injuries, including 4 deaths

Boston Scientific is recalling the catheters associated with its POLARx Cryoablation System due to a heightened risk of esophageal injury. The FDA has ruled that this a Class I recall.

Video of SNMMI President Cathy Cutler explaining the efforts to get U.S. production started for Mo-99 for a domestic supply of nuclear imaging isotopes. #RSNA #SNMMI #RSNA24 #RSNA2024 #isotopeshortage

U.S. moves closer to establishing domestic supply of Mo-99 for nuclear imaging

Society of Nuclear Medicine and Molecular Imaging President, Cathy Cutler, explains the long road to jump-starting a new U.S. domestic supply of imaging isotopes.

Around the web

Cardiovascular Business

FDA clears Apple Watch algorithm for detecting hypertension

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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