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Week in Review: FDA reviews patient injuries | America’s heart failure epidemic | A new recall | A call to action | TAVR trends

News You Need to Know Today
Week in Review: FDA reviews patient injuries | America’s heart failure epidemic | A new recall | A call to action | TAVR trends
Saturday, September 27, 2025
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This Week’s News

FDA investigating Johnson & Johnson medical devices again after 5 injuries

To address this latest safety concern, the third in three months, the company is updating each device and then returning it to the customer.

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warning safety alert recall healthcare issue
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FDA investigating Johnson & Johnson medical devices again after 5 injuries

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warning safety alert recall healthcare issue
To address this latest safety concern, the third in three months, the company is updating each device and then returning it to the customer.
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Top US heart hospital launches new AI research lab

Mount Sinai Fuster Heart Hospital aims to take its use of AI during interventional procedures to the next level and find new ways to transform patient care. 

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artificial intelligence AI predictive analytics
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Top US heart hospital launches new AI research lab

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artificial intelligence AI predictive analytics
Mount Sinai Fuster Heart Hospital aims to take its use of AI during interventional procedures to the next level and find new ways to transform patient care. 
READ MORE >

America’s heart failure epidemic is getting worse

Approximately one in four Americans will develop heart failure in their lifetime, according to a new report from the Heart Failure Society of America. What can be done to combat this worrisome trend?

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heart data research doctor cardiologist AI
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America’s heart failure epidemic is getting worse

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heart data research doctor cardiologist AI
Approximately one in four Americans will develop heart failure in their lifetime, according to a new report from the Heart Failure Society of America. What can be done to combat this worrisome trend?
READ MORE >

CVD responsible for 1 in 3 deaths around the world

Cardiovascular disease remains the world’s leading cause of death, according to a special report from the American College of Cardiology. The new analysis, described by one cardiologist as a "wake-up call," includes data from more than 200 countries and territories.

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Compensation for U.S. cardiologists is up across the board, according to a recent survey published by MedAxiom, an American College of Cardiology company. The report identified similar trends for cardiovascular surgeons, highlighting the country’s high demand for all heart specialists in 2024 and beyond.
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CVD responsible for 1 in 3 deaths around the world

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Compensation for U.S. cardiologists is up across the board, according to a recent survey published by MedAxiom, an American College of Cardiology company. The report identified similar trends for cardiovascular surgeons, highlighting the country’s high demand for all heart specialists in 2024 and beyond.
Cardiovascular disease remains the world’s leading cause of death, according to a special report from the American College of Cardiology. The new analysis, described by one cardiologist as a "wake-up call," includes data from more than 200 countries and territories.
READ MORE >

Safety concern with Johnson & Johnson heart pump controllers leads to Class I recall

Some controllers were assembled with an incorrect part, potentially impacting device performance. The FDA shared an early alert about this issue in August. It has been linked to one patient's death. 

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Safety concern with Johnson & Johnson heart pump controllers leads to Class I recall

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the words "FDA recall" on a board
Some controllers were assembled with an incorrect part, potentially impacting device performance. The FDA shared an early alert about this issue in August. It has been linked to one patient's death. 
READ MORE >

TAVR reinterventions: What new data tell us about redo, explant trends over time

TAVR reintervention rates remain low. However, they are slowly rising as the procedure is used more to treat patients with severe aortic stenosis. Researchers think this trend may continue going forward.

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Tiny fragments of plastic are commonly found deep inside the human body. Heart surgery, it seems, is one of many ways these microplastics are reaching their destination.  Surgeons Operating On Patient
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TAVR reinterventions: What new data tell us about redo, explant trends over time

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Tiny fragments of plastic are commonly found deep inside the human body. Heart surgery, it seems, is one of many ways these microplastics are reaching their destination.  Surgeons Operating On Patient
TAVR reintervention rates remain low. However, they are slowly rising as the procedure is used more to treat patients with severe aortic stenosis. Researchers think this trend may continue going forward.
READ MORE >

FDA clears next-generation platform for AI-powered heart assessments

An updated version of Heartflow's Plaque Analysis platform has gained FDA clearance. In addition, the company announced that Cigna will cover the platform going forward.

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Heartflow's Plaque Analysis AI-driven software that automtically assesses the coronary arteries, maps them and adds markers for areas of interest with plaque.
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FDA clears next-generation platform for AI-powered heart assessments

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Heartflow's Plaque Analysis AI-driven software that automtically assesses the coronary arteries, maps them and adds markers for areas of interest with plaque.
An updated version of Heartflow's Plaque Analysis platform has gained FDA clearance. In addition, the company announced that Cigna will cover the platform going forward.
READ MORE >

Nuclear imaging groups share new flurpiridaz guideline

Several groups collaborated on the document, which is designed to help clinicians provide high-quality, consistent care when using flurpiridaz during cardiac PET imaging exams. 

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Imagers reviewing flurpiridaz F-18 (Flyrcado) myocardial perfusion PET images. Image from GE Healthcare
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Nuclear imaging groups share new flurpiridaz guideline

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Imagers reviewing flurpiridaz F-18 (Flyrcado) myocardial perfusion PET images. Image from GE Healthcare
Several groups collaborated on the document, which is designed to help clinicians provide high-quality, consistent care when using flurpiridaz during cardiac PET imaging exams. 
READ MORE >

A call to action for pediatric cardiologists: CVD prevention begins at childhood

Pediatric cardiologists can make a significant impact on global health trends by looking for early warning signs of CVD in their patients and collaborating with other physicians.

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childrens-health-doctors_thumb.jpg
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A call to action for pediatric cardiologists: CVD prevention begins at childhood

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childrens-health-doctors_thumb.jpg
Pediatric cardiologists can make a significant impact on global health trends by looking for early warning signs of CVD in their patients and collaborating with other physicians.
READ MORE >

Stroke risk much higher for TAVR patients with carotid artery stenosis

Screening TAVR patients for CAS may provide significant value, according to a new meta-analysis of 15 different studies.

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stroke
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Stroke risk much higher for TAVR patients with carotid artery stenosis

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stroke
Screening TAVR patients for CAS may provide significant value, according to a new meta-analysis of 15 different studies.
READ MORE >

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