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New issue with heart pump controllers linked to patient death | AI detects risk of high Lp(a) levels | A sneak peak of TCT 2025

News You Need to Know Today
New issue with heart pump controllers linked to patient death | AI detects risk of high Lp(a) levels | A sneak peak of TCT 2025
Thursday, August 28, 2025
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Today's News and Trends

FDA details new risk with Johnson & Johnson heart pump controllers after patient’s death

This latest alert was put in place after Johnson & Johnson MedTech learned that some of its Automated Impella Controllers were built to the wrong specifications, impacting their ability to function. Affected devices should not be used going forward.

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Johnson & Johnson MedTech Automated Impella Controller
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FDA details new risk with Johnson & Johnson heart pump controllers after patient’s death

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Johnson & Johnson MedTech Automated Impella Controller
This latest alert was put in place after Johnson & Johnson MedTech learned that some of its Automated Impella Controllers were built to the wrong specifications, impacting their ability to function. Affected devices should not be used going forward.
READ MORE >

Health systems use AI to target patients who may have elevated Lp(a) levels

"We can start helping people right now, and it would be meaningful if we can raise more awareness to reduce the burden of CVD," explained Katherine Wilemon, founder and CEO of the Family Heart Foundation. 

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An attendee at AHA 2024 looking at educational displays on Lp(a) in the Novartis booth. Photo By Dave Fornell
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Health systems use AI to target patients who may have elevated Lp(a) levels

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An attendee at AHA 2024 looking at educational displays on Lp(a) in the Novartis booth. Photo By Dave Fornell
"We can start helping people right now, and it would be meaningful if we can raise more awareness to reduce the burden of CVD," explained Katherine Wilemon, founder and CEO of the Family Heart Foundation. 
READ MORE >

CRF unveils late-breaking clinical trials for TCT 2025 in San Francisco

This year marks the 37th annual gathering of the popular Transcatheter Cardiovascular Therapeutics conference. What started as a small gathering in 1988 has grown into one of interventional cardiology’s biggest events.

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San Francisco TCT 2025
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CRF unveils late-breaking clinical trials for TCT 2025 in San Francisco

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San Francisco TCT 2025
This year marks the 37th annual gathering of the popular Transcatheter Cardiovascular Therapeutics conference. What started as a small gathering in 1988 has grown into one of interventional cardiology’s biggest events.
READ MORE >

Featured Articles

Oral GLP-1 drug linked to weight loss in patients with and without diabetes—is FDA approval next?

Eli Lilly and Company is back with even more positive data on orforglipron, its oral GLP-1 receptor agonist. The company says it is "moving with urgency" toward gaining key regulatory approvals and getting the drug in the hands of patients.

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Oral GLP-1 drug linked to weight loss in patients with and without diabetes—is FDA approval next?

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Eli Lilly and Company is back with even more positive data on orforglipron, its oral GLP-1 receptor agonist. The company says it is "moving with urgency" toward gaining key regulatory approvals and getting the drug in the hands of patients.
READ MORE >

New York cardiologist headed to prison—DOJ says he paid for referrals, performed unneeded procedures

"Today’s sentence sends a deterrent message to doctors and the healthcare industry," according to a DOJ statement. "If you abuse patient trust for profit, you will face justice."

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court judge gavel business man bankruptcy lawsuit
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New York cardiologist headed to prison—DOJ says he paid for referrals, performed unneeded procedures

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court judge gavel business man bankruptcy lawsuit
"Today’s sentence sends a deterrent message to doctors and the healthcare industry," according to a DOJ statement. "If you abuse patient trust for profit, you will face justice."
READ MORE >

How nuclear cardiology has transformed care for cardiac amyloidosis

Prem Soman, MD, PhD, explained how early detection and new therapies have been game-changers for the treatment and diagnosis of cardiac amyloidosis.

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Prem Soman, MD, PhD, FACC, FRCP, past president of the American Society of Nuclear Cardiology (ASNC), the Richard S. Caligiuri Endowed Chair in Amyloidosis and Heart Failure, director of the Cardiac Amyloidosis Center, director of nuclear cardiology, and a professor of medicine, University of Pittsburgh Medical Center (UPMC) Heart and Vascular Institute. He is presenting the keynote Mario Verani Memorial Lecture at ASNC 2025, where he will discuss transforming cardiac amyloidosis care.
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How nuclear cardiology has transformed care for cardiac amyloidosis

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Prem Soman, MD, PhD, FACC, FRCP, past president of the American Society of Nuclear Cardiology (ASNC), the Richard S. Caligiuri Endowed Chair in Amyloidosis and Heart Failure, director of the Cardiac Amyloidosis Center, director of nuclear cardiology, and a professor of medicine, University of Pittsburgh Medical Center (UPMC) Heart and Vascular Institute. He is presenting the keynote Mario Verani Memorial Lecture at ASNC 2025, where he will discuss transforming cardiac amyloidosis care.
Prem Soman, MD, PhD, explained how early detection and new therapies have been game-changers for the treatment and diagnosis of cardiac amyloidosis.
READ MORE >

In Case You Missed It

AI now embedded in nearly every cardiovascular IT system

Artificial intelligence's role in day-to-day patient care continues to grow. What should health systems and cardiology departments be thinking about as they shop for new technologies?

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Amy Thompson from Signify Research explains integration of AI into CVIS systems
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AI now embedded in nearly every cardiovascular IT system

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Amy Thompson from Signify Research explains integration of AI into CVIS systems
Artificial intelligence's role in day-to-day patient care continues to grow. What should health systems and cardiology departments be thinking about as they shop for new technologies?
READ MORE >

Pericarditis: New guidance takes on the diagnosis and management of a challenging heart condition

Pericarditis, inflammation of the pericardium, accounts for approximately 5% of all emergency department evaluations for chest pain. These new recommendations are designed to help guide clinicians through the ins and outs of patient care. 

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Pericardial Effusion Sizing Evaluation by Echocardiography. Representative (A) small, (B) moderate, and (C) large PEffs (∗). Representative (D) simple PEff with fibrin strands, (E) exudative PEff, and (F) malignant PEff (∗) caused by pericardial mesothelioma. Adapted with permission from Klein et al. Images and caption courtesy of the American College of Cardiology and JACC.pericarditis cardiac imaging
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Pericarditis: New guidance takes on the diagnosis and management of a challenging heart condition

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Pericardial Effusion Sizing Evaluation by Echocardiography. Representative (A) small, (B) moderate, and (C) large PEffs (∗). Representative (D) simple PEff with fibrin strands, (E) exudative PEff, and (F) malignant PEff (∗) caused by pericardial mesothelioma. Adapted with permission from Klein et al. Images and caption courtesy of the American College of Cardiology and JACC.pericarditis cardiac imaging
Pericarditis, inflammation of the pericardium, accounts for approximately 5% of all emergency department evaluations for chest pain. These new recommendations are designed to help guide clinicians through the ins and outs of patient care. 
READ MORE >

High cost of cardiac amyloidosis drugs may limit access for low-income patients

"We cannot accept a system where only those with means can benefit from life-changing drugs. We are a wealthy nation that spends trillions on healthcare. We must ensure that income and wealth do not determine access," explained JACC Editor-in-Chief Harlan M. Krumholz, MD.

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Cardiac amyloidosis ATTR-CM drug promotion at the 2024 American Heart Association meeting.
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High cost of cardiac amyloidosis drugs may limit access for low-income patients

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Cardiac amyloidosis ATTR-CM drug promotion at the 2024 American Heart Association meeting.
"We cannot accept a system where only those with means can benefit from life-changing drugs. We are a wealthy nation that spends trillions on healthcare. We must ensure that income and wealth do not determine access," explained JACC Editor-in-Chief Harlan M. Krumholz, MD.
READ MORE >

In Other News

Lowest dose gadolinium-based contrast agent to date inches closer to FDA approval

Gadoquatrane is now set to go through the regulatory review process on its trek to earning full FDA approval. 

READ MORE >
update policy
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Lowest dose gadolinium-based contrast agent to date inches closer to FDA approval

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update policy
Gadoquatrane is now set to go through the regulatory review process on its trek to earning full FDA approval. 
READ MORE >

Looming end of Medicare rural pay adjustment raises concerns about doctor shortages

Anders Gilberg, senior vice president of government affairs at the Medical Group Management Association, explains why Congress needs to renew the Medicare geographic pay adjustments in rural areas—to make payments competitive with urban areas and help retain physicians in those communities.

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Anders Gilberg, MGA, senior vice president, government affairs at Medical Group Management Association (MGMA) explained the need to renew the Medicare geographic pay adjustments in rural areas to make payments more competitive than urban areas. He said this is vital to help retain physicians in rural areas who otherwise could find higher paying jobs in larger cities.
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Looming end of Medicare rural pay adjustment raises concerns about doctor shortages

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Anders Gilberg, MGA, senior vice president, government affairs at Medical Group Management Association (MGMA) explained the need to renew the Medicare geographic pay adjustments in rural areas to make payments more competitive than urban areas. He said this is vital to help retain physicians in rural areas who otherwise could find higher paying jobs in larger cities.
Anders Gilberg, senior vice president of government affairs at the Medical Group Management Association, explains why Congress needs to renew the Medicare geographic pay adjustments in rural areas—to make payments competitive with urban areas and help retain physicians in those communities.
READ MORE >

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