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Defibrillation leads recalled | Multimodality imagers making an impact | FDA clears hypertension alerts | IVL in Europe

News You Need to Know Today
Defibrillation leads recalled | Multimodality imagers making an impact | FDA clears hypertension alerts | IVL in Europe
Tuesday, September 16, 2025
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Today's News and Trends

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

Safety concerns with certain Boston Scientific leads have 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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Recall | Product recall
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Update: FDA confirms recalls for defibrillation leads after nearly 400 injuries

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Recall | Product recall
Safety concerns with certain Boston Scientific leads have 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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Multimodality imagers play a critical role in modern heart teams

Heart teams continue to play a major role at hospitals and health systems all over the world. Cardiac imagers who have trained in multiple modalities can provide those teams with a significant amount of value.

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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, spoke at a session on the role of cardiac imagers on the heart team. #ASNC
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Multimodality imagers play a critical role in modern heart teams

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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, spoke at a session on the role of cardiac imagers on the heart team. #ASNC
Heart teams continue to play a major role at hospitals and health systems all over the world. Cardiac imagers who have trained in multiple modalities can provide those teams with a significant amount of value.
READ MORE >

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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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.
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FDA clears Apple Watch algorithm for detecting hypertension

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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.
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. 
READ MORE >

Shockwave Medical launches new IVL catheter for challenging lesions in Europe

The balloon-free catheter, which already had a successful launch in the United States, has been associated with positive outcomes and the ability to reach certain lesions more accurately than balloon-based IVL platforms.

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Shockwave Medical Javelin Peripheral IVL Catheter
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Shockwave Medical launches new IVL catheter for challenging lesions in Europe

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Shockwave Medical Javelin Peripheral IVL Catheter
The balloon-free catheter, which already had a successful launch in the United States, has been associated with positive outcomes and the ability to reach certain lesions more accurately than balloon-based IVL platforms.
READ MORE >

Featured Articles

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."

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A gavel and a stethoscope
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Cardiologist sues hospital after he was allegedly let go for sharing safety concerns

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A gavel and a stethoscope
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."
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Why all heart patients should be vaccinated against the flu, COVID-19, RSV

The American College of Cardiology has shared new recommendations highlighting the protective benefits of a variety of vaccines. The new guidance also examines how to speak with patients who are hesitant to be vaccinated. 

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COVID-19 vaccine vaccination myocarditis heart damage inflammation RSNA imaging radiology cardiology
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Why all heart patients should be vaccinated against the flu, COVID-19, RSV

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COVID-19 vaccine vaccination myocarditis heart damage inflammation RSNA imaging radiology cardiology
The American College of Cardiology has shared new recommendations highlighting the protective benefits of a variety of vaccines. The new guidance also examines how to speak with patients who are hesitant to be vaccinated. 
READ MORE >

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

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The Dexcom G7 Continuous Glucose Monitoring System
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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Heart surgeons see more potential in AI than colleagues from other fields

Cardiac surgeons see significant value in AI's ability to assist clinicians with administrative tasks and patient selection. When it comes to making clinical decisions, however, there is still a certain amount of skepticism. 

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AI healthcare doctor surgery procedure artificial intelligence
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Heart surgeons see more potential in AI than colleagues from other fields

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AI healthcare doctor surgery procedure artificial intelligence
Cardiac surgeons see significant value in AI's ability to assist clinicians with administrative tasks and patient selection. When it comes to making clinical decisions, however, there is still a certain amount of skepticism. 
READ MORE >

In Case You Missed It

Johnson & Johnson’s PFA platform is both safe and effective, real-world data confirm

The Varipulse PFA platform, which has already received FDA and CE mark approval, was linked to an adverse event rate of just 0.6%. 

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Biosense Webster, part of Johnson & Johnson MedTech, shared updated data on its Varipulse pulsed field ablation (PFA) system at AF Symposium 2024 in Boston.
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Johnson & Johnson’s PFA platform is both safe and effective, real-world data confirm

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Biosense Webster, part of Johnson & Johnson MedTech, shared updated data on its Varipulse pulsed field ablation (PFA) system at AF Symposium 2024 in Boston.
The Varipulse PFA platform, which has already received FDA and CE mark approval, was linked to an adverse event rate of just 0.6%. 
READ MORE >

Real-world data link semaglutide, tirzepatide to improved heart failure outcomes

GLP-1 drugs have been taking the United States by storm in recent years. According to a new study of more than 90,000 patients, some of these medications can also make a big impact on reducing adverse heart failure outcomes.

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Semaglutide (Wegovy) injector pen. Photo by Dave Fornell
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Real-world data link semaglutide, tirzepatide to improved heart failure outcomes

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Semaglutide (Wegovy) injector pen. Photo by Dave Fornell
GLP-1 drugs have been taking the United States by storm in recent years. According to a new study of more than 90,000 patients, some of these medications can also make a big impact on reducing adverse heart failure outcomes.
READ MORE >

Beta blockers ‘have no effect’ on heart attack patients

One researcher described the study's findings as "one of the most significant advances in heart attack treatment in decades.”

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Patient
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Beta blockers ‘have no effect’ on heart attack patients

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Patient
One researcher described the study's findings as "one of the most significant advances in heart attack treatment in decades.”
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In Other News

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. 

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

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wheelchair
Only 43% of women with disabilities receive American Society of Breast Surgeons-recommended mammography screening services, according to a new single-center study. 
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Short-term breast cancer risk prediction improves when AI combines imaging with personal info

Understanding which women have the greatest short-term risk could enable providers to implement targeted screening strategies to ensure malignancies are caught at the earliest possible stage.

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Breast cancer AI ribbon pink artificial intelligence
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Short-term breast cancer risk prediction improves when AI combines imaging with personal info

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Breast cancer AI ribbon pink artificial intelligence
Understanding which women have the greatest short-term risk could enable providers to implement targeted screening strategies to ensure malignancies are caught at the earliest possible stage.
READ MORE >

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