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Week in Review: FDA's alert about J&J heart pumps | $71M in fraud | A new obstacle for heart patients | Lead approved for LBBAP

News You Need to Know Today
Week in Review: FDA's alert about J&J heart pumps | $71M in fraud | A new obstacle for heart patients | Lead approved for LBBAP
Saturday, February 28, 2026
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This Week’s News

FDA shares new warning about Johnson & Johnson heart pumps after 4 injuries

This represents the latest in a series of safety concerns associated with the Impella platform. The FDA said it is still reviewing the matter and will keep the public informed as new details become available. 

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warning safety alert recall healthcare issue
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FDA shares new warning about Johnson & Johnson heart pumps after 4 injuries

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warning safety alert recall healthcare issue
This represents the latest in a series of safety concerns associated with the Impella platform. The FDA said it is still reviewing the matter and will keep the public informed as new details become available. 
READ MORE >

It’s about to get harder for many Medicare patients to see a cardiologist

UnitedHealthcare now requires patients enrolled in certain Medicare Advantage plans to receive a PCP referral before seeing a cardiologist. On May 1, the insurer will start denying all claims that do not include the necessary referral. UnitedHealthcare argues that "stronger PCP engagement" is good for patient care, but many stakeholders disagree.

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Referral
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It’s about to get harder for many Medicare patients to see a cardiologist

Share on Twitter Share on Facebook Share on Linkedin
Referral
UnitedHealthcare now requires patients enrolled in certain Medicare Advantage plans to receive a PCP referral before seeing a cardiologist. On May 1, the insurer will start denying all claims that do not include the necessary referral. UnitedHealthcare argues that "stronger PCP engagement" is good for patient care, but many stakeholders disagree.
READ MORE >

Vascular imaging at heart of $71M fraud scheme—DOJ announces prison sentences

The years-long scheme involved sending kickbacks to physicians who ordered unnecessary transcranial doppler exams. Two conspirators have now been sentenced to prison and ordered to pay substantial fines.

READ MORE >
Medicare fraud
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Vascular imaging at heart of $71M fraud scheme—DOJ announces prison sentences

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Medicare fraud
The years-long scheme involved sending kickbacks to physicians who ordered unnecessary transcranial doppler exams. Two conspirators have now been sentenced to prison and ordered to pay substantial fines.
READ MORE >

How the rise of AI could lead to efficiency issues and lower reimbursement payments

AI has shown the potential to transform patient care. However, there are more details to consider than many health systems and policymakers realize. 

READ MORE >
Friederike Keating, MD, professor of medicine at the Larner College of Medicine, and director of nuclear cardiology at University of Vermont Health, said artificial intelligence (AI) in medical imaging may actually increase costs and make workflows less efficient in some instances. She said this is a key thing for health systems and policy makers to keep in mind if there is not clear data showing it helps.
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How the rise of AI could lead to efficiency issues and lower reimbursement payments

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Friederike Keating, MD, professor of medicine at the Larner College of Medicine, and director of nuclear cardiology at University of Vermont Health, said artificial intelligence (AI) in medical imaging may actually increase costs and make workflows less efficient in some instances. She said this is a key thing for health systems and policy makers to keep in mind if there is not clear data showing it helps.
AI has shown the potential to transform patient care. However, there are more details to consider than many health systems and policymakers realize. 
READ MORE >

FDA approves new Biotronik pacing lead for LBBAP

The next-generation device includes a stylet-driven lead and a fixed helix. It was designed and developed specifically with LBBAP in mind. 

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Biotronik has secured U.S. Food and Drug Administration (FDA) approval for its Solia CSP S pacing lead for left bundle branch area pacing (LBBAP).
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FDA approves new Biotronik pacing lead for LBBAP

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Biotronik has secured U.S. Food and Drug Administration (FDA) approval for its Solia CSP S pacing lead for left bundle branch area pacing (LBBAP).
The next-generation device includes a stylet-driven lead and a fixed helix. It was designed and developed specifically with LBBAP in mind. 
READ MORE >

Weight-loss surgery protects the heart more than GLP-1 drugs

Both treatment options were found to be effective in a new meta-analysis of nearly 20,000 patients.  Surgery, however, had the most substantial long-term impact.

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weight loss surgery bariatric Roux-en-Y gastric bypass and sleeve gastrectomy
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Weight-loss surgery protects the heart more than GLP-1 drugs

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weight loss surgery bariatric Roux-en-Y gastric bypass and sleeve gastrectomy
Both treatment options were found to be effective in a new meta-analysis of nearly 20,000 patients.  Surgery, however, had the most substantial long-term impact.
READ MORE >

Registry data point to ‘striking shift’ in treatment decisions after FDA approved low-risk TAVR

Many experts still recommend SAVR over TAVR for patients younger than 65 years old with severe aortic stenosis. However, transcatheter treatments are growing more and more popular when these younger patients require a valve replacement.

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cardiologist viewing heart data
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Registry data point to ‘striking shift’ in treatment decisions after FDA approved low-risk TAVR

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cardiologist viewing heart data
Many experts still recommend SAVR over TAVR for patients younger than 65 years old with severe aortic stenosis. However, transcatheter treatments are growing more and more popular when these younger patients require a valve replacement.
READ MORE >

Cardiologist says new legislation would delay flawed payment cuts, preserve access to care

The efficiency adjustment cuts introduced in the 2026 MPFS are based on assumptions many doctors believe to be false. The American Society of Nuclear Cardiology and other medical societies are pushing back.

READ MORE >
Friederike Keating, MD, director, nuclear cardiology, at University of Vermont Health, and chair of American Society of nuclear Cardiology (ASNC) Health Policy Committee, explains the support behind House Bill 7520 that aims to halt the Medicare's 2.5% efficiency adjustment cut to physician payments that was included in the 2025 Medicare Physician Fee Schedule.
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Cardiologist says new legislation would delay flawed payment cuts, preserve access to care

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Friederike Keating, MD, director, nuclear cardiology, at University of Vermont Health, and chair of American Society of nuclear Cardiology (ASNC) Health Policy Committee, explains the support behind House Bill 7520 that aims to halt the Medicare's 2.5% efficiency adjustment cut to physician payments that was included in the 2025 Medicare Physician Fee Schedule.
The efficiency adjustment cuts introduced in the 2026 MPFS are based on assumptions many doctors believe to be false. The American Society of Nuclear Cardiology and other medical societies are pushing back.
READ MORE >

FDA clears AI-powered platform that personalizes care during TAVR, cardiac pacing procedures

The newly cleared CARA System from Cara Medical was designed to help clinicians before and during a variety of cardiac procedures. It provides a personalized 3D map of the patient's cardiac conduction system and then overlays that map onto live fluoroscopic images.

READ MORE >
simulation of the conduction pathway relative to various cardiac structures.
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FDA clears AI-powered platform that personalizes care during TAVR, cardiac pacing procedures

Share on Twitter Share on Facebook Share on Linkedin
simulation of the conduction pathway relative to various cardiac structures.
The newly cleared CARA System from Cara Medical was designed to help clinicians before and during a variety of cardiac procedures. It provides a personalized 3D map of the patient's cardiac conduction system and then overlays that map onto live fluoroscopic images.
READ MORE >

Women of all ages face rising risks of heart disease and stroke—but cardiologists see a path forward

Cardiovascular disease is already the No. 1 killer among women—and new projections from the American Heart Association suggest things are going to get much worse. There are certain things that clinicians and patients can do, however, to help reverse this trend and save countless lives.

READ MORE >
The National Comprehensive Cancer Network has published new patient-friendly breast cancer screening guidelines
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Women of all ages face rising risks of heart disease and stroke—but cardiologists see a path forward

Share on Twitter Share on Facebook Share on Linkedin
The National Comprehensive Cancer Network has published new patient-friendly breast cancer screening guidelines
Cardiovascular disease is already the No. 1 killer among women—and new projections from the American Heart Association suggest things are going to get much worse. There are certain things that clinicians and patients can do, however, to help reverse this trend and save countless lives.
READ MORE >

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