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FDA warns that imaging catheters may be unsafe | The power of AI-based plaque evaluations | Patient's family awarded $45M

News You Need to Know Today
FDA warns that imaging catheters may be unsafe | The power of AI-based plaque evaluations | Patient's family awarded $45M
Monday, April 21, 2025
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Today's News and Trends

FDA warns that certain coronary imaging catheters are being removed from market over safety concerns

A catheter sheath detached during use and was left in the patient’s body. It was successfully removed, but the FDA said it is now evaluating the potential risk to others going forward. There is no official recall at this time.

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Conavi Medical’s Novasight Hybrid System catheter
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FDA warns that certain coronary imaging catheters are being removed from market over safety concerns

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Conavi Medical’s Novasight Hybrid System catheter
A catheter sheath detached during use and was left in the patient’s body. It was successfully removed, but the FDA said it is now evaluating the potential risk to others going forward. There is no official recall at this time.
READ MORE >

AI-based coronary plaque evaluations highlight elevated heart risks in women

“This is the perfect technique to identify high-risk patients who would benefit from intensive therapies,” imaging specialist Gudrun Feuchtner, MD, told Cardiovascular Business.

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Gudrun Feuchtner, MD, MBA, HCM, assistant professor, cardiovascular imaging, Medical University Innsbruck, Department Radiology, explains how artificial intelligence-based quantitative computed tomography (AI QCT) coronary plaque features are better able to predict risk in women, according the the results of the late-breaking CONFIRM2 study at ACC 2025.
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AI-based coronary plaque evaluations highlight elevated heart risks in women

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Gudrun Feuchtner, MD, MBA, HCM, assistant professor, cardiovascular imaging, Medical University Innsbruck, Department Radiology, explains how artificial intelligence-based quantitative computed tomography (AI QCT) coronary plaque features are better able to predict risk in women, according the the results of the late-breaking CONFIRM2 study at ACC 2025.
“This is the perfect technique to identify high-risk patients who would benefit from intensive therapies,” imaging specialist Gudrun Feuchtner, MD, told Cardiovascular Business.
READ MORE >

Family of heart patient who died awarded $45M after suing health system for negligence

The 55-year-old patient woke up experiencing chest pain one morning and an ambulance was called. He was dead just a few hours later. His family's lawsuit argued that delays in care, communication errors and other issues were directly responsible for his death.

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American Heart Association and Joint Commission launch new Comprehensive Heart Attack Center certification.
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Family of heart patient who died awarded $45M after suing health system for negligence

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American Heart Association and Joint Commission launch new Comprehensive Heart Attack Center certification.
The 55-year-old patient woke up experiencing chest pain one morning and an ambulance was called. He was dead just a few hours later. His family's lawsuit argued that delays in care, communication errors and other issues were directly responsible for his death.
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Resilia tissue developed by Edwards Lifesciences linked to long-term benefits

Researchers tracked nearly 1,000 SAVR patients, presenting eight-year data at the Heart Valve Society’s annual meeting in Cairo, Egypt. 

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Edwards Lifesciences INSPIRIS RESILIA Aortic Valve
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Resilia tissue developed by Edwards Lifesciences linked to long-term benefits

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Edwards Lifesciences INSPIRIS RESILIA Aortic Valve
Researchers tracked nearly 1,000 SAVR patients, presenting eight-year data at the Heart Valve Society’s annual meeting in Cairo, Egypt. 
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Featured Articles

Cardiovascular Business announces its Forty Under 40 Class of 2025

We asked readers to nominate individuals who are already making a major impact on the world of cardiovascular health at a young age. We wanted to hear about your best, your brightest, your most radical thinkers; the people who are never satisfied by something being “good enough” or “how it’s always been done.” 

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cvb_40under40_teaser.png
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Cardiovascular Business announces its Forty Under 40 Class of 2025

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cvb_40under40_teaser.png
We asked readers to nominate individuals who are already making a major impact on the world of cardiovascular health at a young age. We wanted to hear about your best, your brightest, your most radical thinkers; the people who are never satisfied by something being “good enough” or “how it’s always been done.” 
READ MORE >

Cardiology, radiology professionals unite to explore the challenges of diagnosing CAD in women

Coronary artery disease is both underdiagnosed and undertreated in women, and they often receive less guideline-recommended care than men. Why do these disparities persist? And what can today’s healthcare providers do to bring about change?

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older female patient and doctor
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Cardiology, radiology professionals unite to explore the challenges of diagnosing CAD in women

Share on Twitter Share on Facebook Share on Linkedin
older female patient and doctor
Coronary artery disease is both underdiagnosed and undertreated in women, and they often receive less guideline-recommended care than men. Why do these disparities persist? And what can today’s healthcare providers do to bring about change?
READ MORE >

Doctor accused of sexual abuse by multiple colleagues identified as prominent cardiologist

The name and employer of a doctor accused of sexually and physically abusing multiple women is no longer being kept from the public. He faces a total of 20 charges, entering a plea of not guilty to all of them. 

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handcuffs arrested arrest jail
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Doctor accused of sexual abuse by multiple colleagues identified as prominent cardiologist

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handcuffs arrested arrest jail
The name and employer of a doctor accused of sexually and physically abusing multiple women is no longer being kept from the public. He faces a total of 20 charges, entering a plea of not guilty to all of them. 
READ MORE >

Cardiologist-founded startup announces FDA clearance, first uses of new TAVR pacing system

“The device takes variability out of the procedure by giving the operator full control while automating ramp-up and back-up algorithms," according to a clinician who used the new technology. "The TAVR procedure is simplified, reducing physician and staff workload."

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Solo Pace Incorporated SoloPace Control System
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Cardiologist-founded startup announces FDA clearance, first uses of new TAVR pacing system

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Solo Pace Incorporated SoloPace Control System
“The device takes variability out of the procedure by giving the operator full control while automating ramp-up and back-up algorithms," according to a clinician who used the new technology. "The TAVR procedure is simplified, reducing physician and staff workload."
READ MORE >

In Case You Missed It

Patients requiring a permanent pacemaker after TAVR face higher long-term risk of death

As TAVR continues to grow in popularity, researchers noted, it becomes more and more important to know how different complications impact long-term outcomes.

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Patients requiring a permanent pacemaker after TAVR face higher long-term risk of death

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As TAVR continues to grow in popularity, researchers noted, it becomes more and more important to know how different complications impact long-term outcomes.
READ MORE >

Quality of care for heart patients does not improve in first year of ACO participation

Researchers tracked patient outcomes through the use of 15 performance measures related to hypertension, coronary artery disease, heart failure and atrial fibrillation.

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A majority of medical devices involved in Class I recalls were never required by the U.S. Food and Drug Administration (FDA) to undergo premarket or postmarket clinical testing, according to new research published in Annals of Internal Medicine.[1]
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Quality of care for heart patients does not improve in first year of ACO participation

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A majority of medical devices involved in Class I recalls were never required by the U.S. Food and Drug Administration (FDA) to undergo premarket or postmarket clinical testing, according to new research published in Annals of Internal Medicine.[1]
Researchers tracked patient outcomes through the use of 15 performance measures related to hypertension, coronary artery disease, heart failure and atrial fibrillation.
READ MORE >

Cardiologist begins term as ACC president with an eye on workforce issues, health equity and more

Christopher M. Kramer, MD, is a longtime cardiologist and cardiac imaging specialist. His one-year term as the head of the American College of Cardiology officially began at the end of ACC.25 in Chicago.

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Christopher Kramer ACC President
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Cardiologist begins term as ACC president with an eye on workforce issues, health equity and more

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Christopher Kramer ACC President
Christopher M. Kramer, MD, is a longtime cardiologist and cardiac imaging specialist. His one-year term as the head of the American College of Cardiology officially began at the end of ACC.25 in Chicago.
READ MORE >

In Other News

AI has come a long way in healthcare, still has a long way to go: Research recap

As AI continues its march through healthcare organizations around the world, the notion that it will replace the sector’s human workers fades but does not disappear. 

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executive office ai artificial intelligence
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AI has come a long way in healthcare, still has a long way to go: Research recap

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executive office ai artificial intelligence
As AI continues its march through healthcare organizations around the world, the notion that it will replace the sector’s human workers fades but does not disappear. 
READ MORE >

Arkansas the 30th state to pass legislation bolstering coverage for breast imaging

Gov. Sarah Huckabee Sanders signed Senate Bill 123 into law on April 14 following its passage by the state legislature, weeks after Virginia passed a similar bill. 

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Little Rock Arkansas Capitol building
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Arkansas the 30th state to pass legislation bolstering coverage for breast imaging

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Little Rock Arkansas Capitol building
Gov. Sarah Huckabee Sanders signed Senate Bill 123 into law on April 14 following its passage by the state legislature, weeks after Virginia passed a similar bill. 
READ MORE >

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