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Week in Review: J&J devices recalled over cybersecurity risk | Pacemaker issues | Compensation hits new high | Labeling updates

News You Need to Know Today
Week in Review: J&J devices recalled over cybersecurity risk | Pacemaker issues | Compensation hits new high | Labeling updates
Saturday, October 18, 2025
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This Week’s News

FDA announces recall for Johnson & Johnson devices due to cybersecurity risk—customers urged to act

The FDA and Johnson & Johnson MedTech are telling customers to keep the devices in a secure environment until they can be disabled from all networks.

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cybersecurity hacker ransomware cyber data breach
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FDA announces recall for Johnson & Johnson devices due to cybersecurity risk—customers urged to act

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cybersecurity hacker ransomware cyber data breach
The FDA and Johnson & Johnson MedTech are telling customers to keep the devices in a secure environment until they can be disabled from all networks.
READ MORE >

FDA details Class I recalls for more than 1 million pacemakers—software update required

The FDA has finalized new Class I recalls related to ongoing safety concerns with Boston Scientific’s Accolade family of pacemakers. A software update is now available to help address the issue, and an additional update is already in the works.

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the words "FDA recall" on a board
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FDA details Class I recalls for more than 1 million pacemakers—software update required

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the words "FDA recall" on a board
The FDA has finalized new Class I recalls related to ongoing safety concerns with Boston Scientific’s Accolade family of pacemakers. A software update is now available to help address the issue, and an additional update is already in the works.
READ MORE >

Cardiologist compensation hits an all-time high

Cardiologists, cardiac surgeons and cardiology APPs all earned more in 2024 than 2023, according to a new survey. Compensation in private practices continues to be much lower than it is integrated practices. 

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Money dollar investments
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Cardiologist compensation hits an all-time high

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Money dollar investments
Cardiologists, cardiac surgeons and cardiology APPs all earned more in 2024 than 2023, according to a new survey. Compensation in private practices continues to be much lower than it is integrated practices. 
READ MORE >

Q&A: What cardiologists know and don’t know about pulsed field ablation

Peter Weiss, MD, a veteran electrophysiologist, sat down with Cardiovascular Business to discuss the ongoing rise of pulsed field ablation. While he's impressed with the technology, he says many questions remain about its long-term value. 

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Heart cardiologists doctors surgery
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Q&A: What cardiologists know and don’t know about pulsed field ablation

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Heart cardiologists doctors surgery
Peter Weiss, MD, a veteran electrophysiologist, sat down with Cardiovascular Business to discuss the ongoing rise of pulsed field ablation. While he's impressed with the technology, he says many questions remain about its long-term value. 
READ MORE >

Long-term data highlight Ross procedure's safety, effectiveness in younger patients

TAVR may get more attention, but the Ross procedure has also gained significant momentum in recent years. Ismail El-Hamamsy, MD, PhD, detailed his own team's success with the complex procedure.

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Ismail El-Hamamsy, MD, PhD, director of aortic surgery for the Mount Sinai Health System, explains the long-term outcomes of the Ross procedure, where a diseased aortic valve is surgically replaced with the patient's own pulmonary valve.
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Long-term data highlight Ross procedure's safety, effectiveness in younger patients

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Ismail El-Hamamsy, MD, PhD, director of aortic surgery for the Mount Sinai Health System, explains the long-term outcomes of the Ross procedure, where a diseased aortic valve is surgically replaced with the patient's own pulmonary valve.
TAVR may get more attention, but the Ross procedure has also gained significant momentum in recent years. Ismail El-Hamamsy, MD, PhD, detailed his own team's success with the complex procedure.
READ MORE >

FDA approves key update for Medtronic’s Endurant stent graft system

Going forward, Medtronic can include clinical evidence related to the treatment of ruptured abdominal aortic aneurysms in the device's labeling. This is the first time an EVAR system has received such an approval.

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Endurant stent graft system labeling
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FDA approves key update for Medtronic’s Endurant stent graft system

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Endurant stent graft system labeling
Going forward, Medtronic can include clinical evidence related to the treatment of ruptured abdominal aortic aneurysms in the device's labeling. This is the first time an EVAR system has received such an approval.
READ MORE >

Medtronic launches full distribution of new 3-in-1 carotid stent

The device, manufactured by Contego Medical, was designed with rising procedure volumes and stroke risks in mind. 

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Contego Medical, a North Carolina-based medical device company, has received U.S. Food and Drug Administration (FDA) approval for its new all-in-one carotid stenting offering, the Neuroguard IEP System.
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Medtronic launches full distribution of new 3-in-1 carotid stent

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Contego Medical, a North Carolina-based medical device company, has received U.S. Food and Drug Administration (FDA) approval for its new all-in-one carotid stenting offering, the Neuroguard IEP System.
The device, manufactured by Contego Medical, was designed with rising procedure volumes and stroke risks in mind. 
READ MORE >

Plant-based diets linked to lower dementia risk for vulnerable heart patients

Adults with a history of CVD, type 2 diabetes and stroke were all associated with a lower dementia risk if they ate a whole food, plant-based diet. The study, published in JACC: Advances, was based on data from more than 71,000 U.K. Biobank participants. 

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doctor fruits vegetables vegetarian diet. Embracing a plant-based diet can improve a person’s cardiovascular health, according to a new commentary published in the American Journal of Cardiology.[1] The article, titled “Are We What We Eat? The Moral Imperative of the Medical Profession to Promote Plant-Based Nutrition,” also highlights multiple reasons that choosing plant-based nutrition over animal-based food can be viewed as being better for society as a whole.
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Plant-based diets linked to lower dementia risk for vulnerable heart patients

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doctor fruits vegetables vegetarian diet. Embracing a plant-based diet can improve a person’s cardiovascular health, according to a new commentary published in the American Journal of Cardiology.[1] The article, titled “Are We What We Eat? The Moral Imperative of the Medical Profession to Promote Plant-Based Nutrition,” also highlights multiple reasons that choosing plant-based nutrition over animal-based food can be viewed as being better for society as a whole.
Adults with a history of CVD, type 2 diabetes and stroke were all associated with a lower dementia risk if they ate a whole food, plant-based diet. The study, published in JACC: Advances, was based on data from more than 71,000 U.K. Biobank participants. 
READ MORE >

Cardiologists perform first TTVR of its kind on recent heart transplant recipient

When a 50-year-old patient developed severe TR just months after receiving a heart transplant, the safest treatment option was to implant an Evoque TTVR device. 

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Edwards Lifesciences Evoque transcatheter tricuspid valve at TCT 2024. DF
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Cardiologists perform first TTVR of its kind on recent heart transplant recipient

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Edwards Lifesciences Evoque transcatheter tricuspid valve at TCT 2024. DF
When a 50-year-old patient developed severe TR just months after receiving a heart transplant, the safest treatment option was to implant an Evoque TTVR device. 
READ MORE >

FDA approves labeling changes for fenofibrates due to lack of cardiovascular benefits

The FDA listened to physician feedback and updated its labeling requirements for fenofibrates. These drugs have not been linked to any significant cardiovascular benefits, and clinicians should act accordingly.

READ MORE >
doctor patient elderly check up hospital
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FDA approves labeling changes for fenofibrates due to lack of cardiovascular benefits

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doctor patient elderly check up hospital
The FDA listened to physician feedback and updated its labeling requirements for fenofibrates. These drugs have not been linked to any significant cardiovascular benefits, and clinicians should act accordingly.
READ MORE >

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