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News You Need to Know Today
Week in Review: Surgical devices recalled | CMS proposes pay bump | New ASE guidelines | AI for real-time TAVR guidance
Saturday, July 19, 2025
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Today's News and Trends

FDA details multiple Class I recalls for Edwards Lifesciences surgical devices

Edwards Lifesciences has recalled more than 61,000 medical devices due to the risk of a small piece of wire becoming exposed. No patient injuries have been reported at this time.

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Product Recall
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FDA details multiple Class I recalls for Edwards Lifesciences surgical devices

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Product Recall
Edwards Lifesciences has recalled more than 61,000 medical devices due to the risk of a small piece of wire becoming exposed. No patient injuries have been reported at this time.
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CMS proposes Medicare coverage for renal denervation

This proposal, if finalized, would dramatically increase patient access to renal denervation. Both Recor Medical and Medtronic have shared their excitement over the news.

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The Medtronic Symplicity Spyral Renal Denervation system uses a catheter that curls in the renal artery to place radiofrequency electrodes against the vessel wall to ablate the nerves that control vasodilation, so the artery can be propped in the fully open position.
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CMS proposes Medicare coverage for renal denervation

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The Medtronic Symplicity Spyral Renal Denervation system uses a catheter that curls in the renal artery to place radiofrequency electrodes against the vessel wall to ablate the nerves that control vasodilation, so the artery can be propped in the fully open position.
This proposal, if finalized, would dramatically increase patient access to renal denervation. Both Recor Medical and Medtronic have shared their excitement over the news.
READ MORE >

CMS proposal includes cardiologist pay bump—cuts to high-value services still a concern

The 2026 MPFS proposed rule includes higher conversion factors across the board. However, some cardiology groups remain concerned about a series of reimbursement reductions for high-value cardiology services. 

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Among general cardiologists, for example, median compensation jumped nearly 8% from 2023 to 2024. Interventional cardiology and electrophysiology saw even larger jumps. Dollar money graphic showing increased finance.
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CMS proposal includes cardiologist pay bump—cuts to high-value services still a concern

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Among general cardiologists, for example, median compensation jumped nearly 8% from 2023 to 2024. Interventional cardiology and electrophysiology saw even larger jumps. Dollar money graphic showing increased finance.
The 2026 MPFS proposed rule includes higher conversion factors across the board. However, some cardiology groups remain concerned about a series of reimbursement reductions for high-value cardiology services. 
READ MORE >

ASE shares new recommendations for evaluating LV diastolic function, HFpEF

The new guidelines detail the use of echocardiography to evaluate patients for a variety of conditions.

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Agfa automated echo measurements on echo report CVIS at ASE 2023. An updated guideline from the American Society of Echocardiography (ASE) offers new echocardiographic parameters and recommendations for clinicians evaluating patients for possible heart failure. "The Recommendations for the Evaluation of Left Ventricular Diastolic Function by Echocardiography and for Heart Failure With Preserved Ejection Fraction (HFpEF) Diagnosis) was published in the July 2025 issue of the Journal of the ASE.
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ASE shares new recommendations for evaluating LV diastolic function, HFpEF

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Agfa automated echo measurements on echo report CVIS at ASE 2023. An updated guideline from the American Society of Echocardiography (ASE) offers new echocardiographic parameters and recommendations for clinicians evaluating patients for possible heart failure. "The Recommendations for the Evaluation of Left Ventricular Diastolic Function by Echocardiography and for Heart Failure With Preserved Ejection Fraction (HFpEF) Diagnosis) was published in the July 2025 issue of the Journal of the ASE.
The new guidelines detail the use of echocardiography to evaluate patients for a variety of conditions.
READ MORE >

Yes, researchers argue, vitamin D supplements help protect the heart

The ongoing debate continues. The team behind this latest analysis pointed to more than 40 years of research to make its point.

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vitamin d supplement heart health CVD
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Yes, researchers argue, vitamin D supplements help protect the heart

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vitamin d supplement heart health CVD
The ongoing debate continues. The team behind this latest analysis pointed to more than 40 years of research to make its point.
READ MORE >

AI-enabled coronary plaque evaluations included in new RBM guidelines

The use of advanced AI software to assess CCTA images continues to gain more momentum.

READ MORE >
HeartFlow Plaque Analysis Example
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AI-enabled coronary plaque evaluations included in new RBM guidelines

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HeartFlow Plaque Analysis Example
The use of advanced AI software to assess CCTA images continues to gain more momentum.
READ MORE >

FDA clears AI-powered software for real-time TAVR guidance

Caranx Medical is focused on using AI, robotics and other advanced technologies to expand patient access to life-saving procedures. This new software, for example, helps guide cardiologists through complex TAVR procedures.

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Caranx Medical TAVIPILOT
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FDA clears AI-powered software for real-time TAVR guidance

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Caranx Medical TAVIPILOT
Caranx Medical is focused on using AI, robotics and other advanced technologies to expand patient access to life-saving procedures. This new software, for example, helps guide cardiologists through complex TAVR procedures.
READ MORE >

FDA approves Bayer's finerenone to treat wide range of heart failure patients

Finerenone, sold by Bayer under the brand name Kerendia, is now approved in the United States for the treatment of HFmrEF and HFpEF. The drug has already been used for years to treat patients with chronic kidney disease and type 2 diabetes.

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Bayer finerenone Kerendia heart failure MOONRAKER
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FDA approves Bayer's finerenone to treat wide range of heart failure patients

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Bayer finerenone Kerendia heart failure MOONRAKER
Finerenone, sold by Bayer under the brand name Kerendia, is now approved in the United States for the treatment of HFmrEF and HFpEF. The drug has already been used for years to treat patients with chronic kidney disease and type 2 diabetes.
READ MORE >

AI-enhanced echocardiography improves early detection of cardiac amyloidosis

The first FDA-cleared AI model of its kind was found to be an accurate screening tool for cardiac amyloidosis.

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Ultromics EchoGo Amyloidosis artificial intelligence. A first of its kind AI model developed by Mayo Clinic and Ultromics Ltd., was found to be highly accurate in screening for cardiac amyloidosis in a large 2,612 patient clinical trial. The findings were published in the European Heart Journal.[1] Mayo Clinic, investigators at the University of Chicago Medicine and collaborators around the world at other sites, validated and tested the model on a large and multi-ethnic population.
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AI-enhanced echocardiography improves early detection of cardiac amyloidosis

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Ultromics EchoGo Amyloidosis artificial intelligence. A first of its kind AI model developed by Mayo Clinic and Ultromics Ltd., was found to be highly accurate in screening for cardiac amyloidosis in a large 2,612 patient clinical trial. The findings were published in the European Heart Journal.[1] Mayo Clinic, investigators at the University of Chicago Medicine and collaborators around the world at other sites, validated and tested the model on a large and multi-ethnic population.
The first FDA-cleared AI model of its kind was found to be an accurate screening tool for cardiac amyloidosis.
READ MORE >

Update to Johnson & Johnson PFA platform gains FDA approval

The Varipulse PFA platform originally gained FDA approval in 2024. According to Johnson & Johnson MedTech, this update was put in place to help the technology provide better patient outcomes going forward.

READ MORE >
The late-breaking U.S. multicenter admIRE clinical trial at the Heart Rhythm Society 2024 meeting, showed positive data on the long-term safety and effectiveness of the the Biosense Webster Varipulse pulsed field ablation (PFA) system in patients with paroxysmal atrial fibrillation. #HRS #HRS2024 #PFA
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Update to Johnson & Johnson PFA platform gains FDA approval

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The late-breaking U.S. multicenter admIRE clinical trial at the Heart Rhythm Society 2024 meeting, showed positive data on the long-term safety and effectiveness of the the Biosense Webster Varipulse pulsed field ablation (PFA) system in patients with paroxysmal atrial fibrillation. #HRS #HRS2024 #PFA
The Varipulse PFA platform originally gained FDA approval in 2024. According to Johnson & Johnson MedTech, this update was put in place to help the technology provide better patient outcomes going forward.
READ MORE >

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