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News You Need to Know Today
CMS makes major TAVR changes | Stryker recalls AEDs | A new CVD risk factor | Cardiac PET Alliance launches | FDA OKs TAVR tech
Friday, September 11, 2026
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Today's News and Trends

CMS finalizes sweeping TAVR changes, including Medicare coverage for asymptomatic patients

After months of consideration, CMS has officially signed off on major changes to its TAVR policies. The treatment of asymptomatic patients is now covered by Medicare, for example, and fewer reporting requirements are in place when symptomatic patients undergo treatment.

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Heart cardiologists doctors surgery
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CMS finalizes sweeping TAVR changes, including Medicare coverage for asymptomatic patients

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Heart cardiologists doctors surgery
After months of consideration, CMS has officially signed off on major changes to its TAVR policies. The treatment of asymptomatic patients is now covered by Medicare, for example, and fewer reporting requirements are in place when symptomatic patients undergo treatment.
READ MORE >

Stryker recalls AEDs due to malfunction risk

If a malfunction does occur, Stryker warned, it could impact the device's effectiveness. No adverse events have been reported at this time.

READ MORE >
Stryker is recalling nearly 12,000 HeartSine automated external defibrillators (AEDs) due to a risk of the devices failing to deliver the intended therapy. If such a failure does occur, it could lead to therapy being delayed or not being delivered at all.
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Stryker recalls AEDs due to malfunction risk

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Stryker is recalling nearly 12,000 HeartSine automated external defibrillators (AEDs) due to a risk of the devices failing to deliver the intended therapy. If such a failure does occur, it could lead to therapy being delayed or not being delivered at all.
If a malfunction does occur, Stryker warned, it could impact the device's effectiveness. No adverse events have been reported at this time.
READ MORE >

A new CVD risk factor emerges: Too much light exposure at night is bad for the heart

A new study of more than 11,000 patients suggests that darkness is necessary for the heart to function at full strength. “Light pollution has emerged as a new risk factor for cardiovascular disease," one researcher explained. 

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woman sleeps with lamp on
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A new CVD risk factor emerges: Too much light exposure at night is bad for the heart

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woman sleeps with lamp on
A new study of more than 11,000 patients suggests that darkness is necessary for the heart to function at full strength. “Light pollution has emerged as a new risk factor for cardiovascular disease," one researcher explained. 
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New national coalition pushes for wider cardiac PET adoption

The Cardiac PET Alliance said it wants to advance education, research and advocacy surrounding cardiac PET imaging. 

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A patient undergoing set up prior to a cardiac PET-CT scan at Rush University Medical Center in Chicago. Photo by Dave Fornell. Marilyn Fornell
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New national coalition pushes for wider cardiac PET adoption

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A patient undergoing set up prior to a cardiac PET-CT scan at Rush University Medical Center in Chicago. Photo by Dave Fornell. Marilyn Fornell
The Cardiac PET Alliance said it wants to advance education, research and advocacy surrounding cardiac PET imaging. 
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FDA approves new device for capturing debris during TAVR

The Emboliner Embolic Protection System held its own in a recent head-to-head comparison with Boston Scientific’s Sentinel Cerebral Protection System. With FDA approval now secured, Emboline hopes to launch the device in the months ahead. 

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Emboliner® Embolic Protection System
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FDA approves new device for capturing debris during TAVR

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Emboliner® Embolic Protection System
The Emboliner Embolic Protection System held its own in a recent head-to-head comparison with Boston Scientific’s Sentinel Cerebral Protection System. With FDA approval now secured, Emboline hopes to launch the device in the months ahead. 
READ MORE >

Featured Articles

Hormonal changes a key detail when assessing cardiovascular risk in a female patient

Questions about menopause, oral contraceptive use and hormone replacement therapy should all be part of the conversation when evaluating a woman's cardiovascular health.

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Ady Orbach, MD, MSc, MBA, FESC, a cardiologist and multimodality cardiac imager at the Edith Wolfson Medical Center, Holon, Israel, explains the impact of women's hormones on the cardiovascular system and why cardiac imagers should pay attention. The women having chest pain art is by Patrcia Carrascosa, displayed at RSNA 2025.
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Hormonal changes a key detail when assessing cardiovascular risk in a female patient

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Ady Orbach, MD, MSc, MBA, FESC, a cardiologist and multimodality cardiac imager at the Edith Wolfson Medical Center, Holon, Israel, explains the impact of women's hormones on the cardiovascular system and why cardiac imagers should pay attention. The women having chest pain art is by Patrcia Carrascosa, displayed at RSNA 2025.
Questions about menopause, oral contraceptive use and hormone replacement therapy should all be part of the conversation when evaluating a woman's cardiovascular health.
READ MORE >

American Society of Nuclear Cardiology updates cardiac stress testing guideline

The new ASNC document includes detailed SPECT- and PET-specific protocols, patient preparation recommendations and a fresh look at safety.

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Patient set up for a cardiac PET-CT scan at Rush University Medical Center in Chicago. Photo by Dave Fornell. Marilyn Fornell
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American Society of Nuclear Cardiology updates cardiac stress testing guideline

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Patient set up for a cardiac PET-CT scan at Rush University Medical Center in Chicago. Photo by Dave Fornell. Marilyn Fornell
The new ASNC document includes detailed SPECT- and PET-specific protocols, patient preparation recommendations and a fresh look at safety.
READ MORE >

FDA clears updates to new platform for cardiac imaging, visualization and navigation

The end-to-end platform provides ultrasound imaging courtesy of a 360° catheter that creates real-time 2D and 3D maps of the patient’s heart. It also offers advanced visualization and navigation capabilities.

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Luma Vision Verafeye
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FDA clears updates to new platform for cardiac imaging, visualization and navigation

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Luma Vision Verafeye
The end-to-end platform provides ultrasound imaging courtesy of a 360° catheter that creates real-time 2D and 3D maps of the patient’s heart. It also offers advanced visualization and navigation capabilities.
READ MORE >

Heart failure before and after TAVR: New data point to ongoing concerns

A majority of TAVR patients also present with a history of heart failure. New research suggests many of them are not being prescribed the medications they need.

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IVUS guidance during DES implantation boosts long-term outcomes in new study
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Heart failure before and after TAVR: New data point to ongoing concerns

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IVUS guidance during DES implantation boosts long-term outcomes in new study
A majority of TAVR patients also present with a history of heart failure. New research suggests many of them are not being prescribed the medications they need.
READ MORE >

In Case You Missed It

Philips recalls Cardiac Workstation systems due to software issue—users urged to follow new guidance

These systems do not need to be returned to the manufacturer. However, users are urged to follow specific instructions to avoid any issues.

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FDA Recall
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Philips recalls Cardiac Workstation systems due to software issue—users urged to follow new guidance

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FDA Recall
These systems do not need to be returned to the manufacturer. However, users are urged to follow specific instructions to avoid any issues.
READ MORE >

AI-powered opportunistic screening could help find patients with undetected aortic stenosis

Having AI that can recognize and report signs of aortic stenosis in noncardiac imaging scans would make a major impact on patient care. 

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Aortic stenosis opportunistic CT AI imaging from SCCT 2026 presentation by Ofir Koren, MD, Cedards-Sinai.
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AI-powered opportunistic screening could help find patients with undetected aortic stenosis

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Aortic stenosis opportunistic CT AI imaging from SCCT 2026 presentation by Ofir Koren, MD, Cedards-Sinai.
Having AI that can recognize and report signs of aortic stenosis in noncardiac imaging scans would make a major impact on patient care. 
READ MORE >

Transfemoral TMVR linked to positive outcomes for high-risk heart patients, new data confirm

Researchers tracked several years of data from patients treated with one of nine different devices. They described the reduction in MR as “profound and durable.”

READ MORE >
The Sapien M3 system for transcatheter mitral valve replacement. Image courtesy of Edwards Lifesciences.
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Transfemoral TMVR linked to positive outcomes for high-risk heart patients, new data confirm

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The Sapien M3 system for transcatheter mitral valve replacement. Image courtesy of Edwards Lifesciences.
Researchers tracked several years of data from patients treated with one of nine different devices. They described the reduction in MR as “profound and durable.”
READ MORE >

In Other News

Experts say radiology departments must adapt to 'obesity pandemic'

Imaging leaders may need to rethink equipment, protocols and workflows as obesity continues to affect a growing share of the population, according to a new analysis. 

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Obesity Paradox Body Mass Index
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Experts say radiology departments must adapt to 'obesity pandemic'

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Obesity Paradox Body Mass Index
Imaging leaders may need to rethink equipment, protocols and workflows as obesity continues to affect a growing share of the population, according to a new analysis. 
READ MORE >

Proposal to bring universal single-payer coverage to Pennsylvania enters House committee

If passed, House Bill 2763 would develop a state-run system to cover the costs of healthcare delivery for every resident of the state. A companion bill is soon to be introduced in the state Senate.

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health insurance
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Proposal to bring universal single-payer coverage to Pennsylvania enters House committee

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health insurance
If passed, House Bill 2763 would develop a state-run system to cover the costs of healthcare delivery for every resident of the state. A companion bill is soon to be introduced in the state Senate.
READ MORE >

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