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News You Need to Know Today
A new Watchman risk | FTC challenges medtech deal | Catheters recalled | Safety issue linked to 16 deaths | AI for HF screening
Thursday, August 7, 2025
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Today's News and Trends

FDA says Watchman access systems may increase risk of air embolism—17 deaths reported

Because of this risk, which has been associated with 120 serious injuries, Boston Scientific is updating the instructions for use of several Watchman access systems.

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Watchman TruSteer Access System
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FDA says Watchman access systems may increase risk of air embolism—17 deaths reported

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Watchman TruSteer Access System
Because of this risk, which has been associated with 120 serious injuries, Boston Scientific is updating the instructions for use of several Watchman access systems.
READ MORE >

FTC challenges ‘anticompetitive’ TAVR acquisition

The FTC is working to stop Edwards Lifesciences from completing its acquisition of JenaValve. Edwards, however, is not backing down.

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merger acquisition M&A business
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FTC challenges ‘anticompetitive’ TAVR acquisition

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merger acquisition M&A business
The FTC is working to stop Edwards Lifesciences from completing its acquisition of JenaValve. Edwards, however, is not backing down.
READ MORE >

FDA details defibrillation lead issue linked to 386 injuries, 16 deaths

Boston Scientific manufactured these devices from 2002 to 2021, and approximately 354,000 are still in use. It is recommended that clinicians look for early signs of this issue during scheduled follow-up appointments.

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U.S. FDA Sign
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FDA details defibrillation lead issue linked to 386 injuries, 16 deaths

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U.S. FDA Sign
Boston Scientific manufactured these devices from 2002 to 2021, and approximately 354,000 are still in use. It is recommended that clinicians look for early signs of this issue during scheduled follow-up appointments.
READ MORE >

FDA announces new recall of reprocessed EP catheters due to risk of contamination

Customers with these devices on hand are asked to return them right away. No serious injuries have been reported at this time, but the presence of residual particulates can lead to such side effects as pulmonary embolism and deep vein thrombosis.

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Reprocessed Supreme Fixed Electrophysiology Catheter
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FDA announces new recall of reprocessed EP catheters due to risk of contamination

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Reprocessed Supreme Fixed Electrophysiology Catheter
Customers with these devices on hand are asked to return them right away. No serious injuries have been reported at this time, but the presence of residual particulates can lead to such side effects as pulmonary embolism and deep vein thrombosis.
READ MORE >

Algorithm brings early heart failure screening to primary care office visits

Most patients are first diagnosed with heart failure in an emergency room or hospital, when their symptoms are already severe. This advanced algorithm could change all that by opening up screening to many more patients. 

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The Ventric Health Vivio AI system screens for elevated left ventricular end-diastolic pressure, or filling pressure (LVEDP) quickly with a a five-minute, noninvasive test using a blood pressure cuff, single-lead Bluetooth-enabled ECG, and proprietary algorithm. This can be performed in a single primary care office visit.
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Algorithm brings early heart failure screening to primary care office visits

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The Ventric Health Vivio AI system screens for elevated left ventricular end-diastolic pressure, or filling pressure (LVEDP) quickly with a a five-minute, noninvasive test using a blood pressure cuff, single-lead Bluetooth-enabled ECG, and proprietary algorithm. This can be performed in a single primary care office visit.
Most patients are first diagnosed with heart failure in an emergency room or hospital, when their symptoms are already severe. This advanced algorithm could change all that by opening up screening to many more patients. 
READ MORE >

CCTA outperforms TEE after LAAO, new meta-analysis confirms

Researchers reviewed data from more than 1,300 patients who underwent both CCTA and TEE after undergoing LAAO. The two modalities were comparable in many ways, but cardiac CT was linked to a few key benefits.

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A CTA scan being performed at Beaumont Hospital in Michigan by cardiac CT expert Kavitha M Chinnaiyan, MD. CCTA has largely been used at academic medical centers for the past decade, but it is now expanding in 2022 to community hospitals and clinics thanks to a Class 1A recommendation in the 2021 chest pain guidelines. #CCTA #CTA #Beaumont
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CCTA outperforms TEE after LAAO, new meta-analysis confirms

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A CTA scan being performed at Beaumont Hospital in Michigan by cardiac CT expert Kavitha M Chinnaiyan, MD. CCTA has largely been used at academic medical centers for the past decade, but it is now expanding in 2022 to community hospitals and clinics thanks to a Class 1A recommendation in the 2021 chest pain guidelines. #CCTA #CTA #Beaumont
Researchers reviewed data from more than 1,300 patients who underwent both CCTA and TEE after undergoing LAAO. The two modalities were comparable in many ways, but cardiac CT was linked to a few key benefits.
READ MORE >

Featured Articles

New LAAO guidelines: 6 key takeaways for interventional cardiologists and electrophysiologists

SCAI and HRS have collaborated on new guidelines designed to help clinicians make the safest, smartest treatment decisions possible.

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Newsweek ranked the 50 best heart hospitals in the world
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New LAAO guidelines: 6 key takeaways for interventional cardiologists and electrophysiologists

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Newsweek ranked the 50 best heart hospitals in the world
SCAI and HRS have collaborated on new guidelines designed to help clinicians make the safest, smartest treatment decisions possible.
READ MORE >

How economic forces are reshaping the future of cardiac care

Karen Joynt Maddox, MD, MPH, explained the many ways cardiology's business models are starting to evolve. She also touched on a number of other topics, including AI and the power of prevention.

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Karen Joynt Maddox discusses macroeconomic factors pressuring traditional models of cardiac care.
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How economic forces are reshaping the future of cardiac care

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Karen Joynt Maddox discusses macroeconomic factors pressuring traditional models of cardiac care.
Karen Joynt Maddox, MD, MPH, explained the many ways cardiology's business models are starting to evolve. She also touched on a number of other topics, including AI and the power of prevention.
READ MORE >

AI company raises $55M with help from leading health systems

Ultromics plans to use the new funds to help expand its presence throughout the United States. In addition, the company is focused on developing additional AI-enabled software offerings.

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artificial intelligence heart AI
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AI company raises $55M with help from leading health systems

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artificial intelligence heart AI
Ultromics plans to use the new funds to help expand its presence throughout the United States. In addition, the company is focused on developing additional AI-enabled software offerings.
READ MORE >

In Case You Missed It

Q&A: What Medicare covering TriClip means for heart patients with leaky tricuspid valves

The tricuspid valve has been at the center of several key policy shifts in recent years. In fact, Medicare now covers both T-TEER and TTVR when performed with FDA-approved devices. We spoke to interventional cardiologist Jason H. Rogers, MD, to learn more about how this momentum has impacted patient care. 

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cardiologist Jason H. Rogers, MD, a professor at UC Davis Medical Center in Sacramento, California
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Q&A: What Medicare covering TriClip means for heart patients with leaky tricuspid valves

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cardiologist Jason H. Rogers, MD, a professor at UC Davis Medical Center in Sacramento, California
The tricuspid valve has been at the center of several key policy shifts in recent years. In fact, Medicare now covers both T-TEER and TTVR when performed with FDA-approved devices. We spoke to interventional cardiologist Jason H. Rogers, MD, to learn more about how this momentum has impacted patient care. 
READ MORE >

Widespread use of polypills could prevent up to 72 million heart disease deaths

Targeting high-risk patients with single-pill combination therapies, also known as polypills, could change healthcare on a global scale, according new data published in the Journal of the American College of Cardiology. 

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The World Health Organization (WHO) has officially endorsed the use of polypills—fixed combinations of multiple medicines contained in a single pill—for the prevention of cardiovascular disease, adding them to the latest edition of the WHO Model List of Essential Medicines.
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Widespread use of polypills could prevent up to 72 million heart disease deaths

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The World Health Organization (WHO) has officially endorsed the use of polypills—fixed combinations of multiple medicines contained in a single pill—for the prevention of cardiovascular disease, adding them to the latest edition of the WHO Model List of Essential Medicines.
Targeting high-risk patients with single-pill combination therapies, also known as polypills, could change healthcare on a global scale, according new data published in the Journal of the American College of Cardiology. 
READ MORE >

In Other News

Healthcare AI today: Whom to sue, invite into AI governance and altogether avoid (unless you want a new religion)

The question of legal responsibility for AI gone wrong in healthcare remains unsettled. The only sure thing is a lot of finger pointing. 

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tech person
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Healthcare AI today: Whom to sue, invite into AI governance and altogether avoid (unless you want a new religion)

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tech person
The question of legal responsibility for AI gone wrong in healthcare remains unsettled. The only sure thing is a lot of finger pointing. 
READ MORE >

AI-equipped wearables may have an important future in public health surveillance

Wearable health devices outfitted with AI seem poised to transition from consumer novelties to an integral layer of U.S. public-health intelligence. 

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wearable health device
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AI-equipped wearables may have an important future in public health surveillance

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wearable health device
Wearable health devices outfitted with AI seem poised to transition from consumer novelties to an integral layer of U.S. public-health intelligence. 
READ MORE >

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