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Reprocessed EP catheters recalled | TAVR outcomes for men & women | The evolving ECG market | Updated instructions | PE research

News You Need to Know Today
Reprocessed EP catheters recalled | TAVR outcomes for men & women | The evolving ECG market | Updated instructions | PE research
Wednesday, February 11, 2026
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Today's News and Trends

Reprocessed EP catheters recalled due to contamination risk

The FDA has announced seven Class I recalls related to this issue. Customers are urged to destroy the devices immediately instead of returning them to the manufacturer. 

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Product Recall
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Reprocessed EP catheters recalled due to contamination risk

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Product Recall
The FDA has announced seven Class I recalls related to this issue. Customers are urged to destroy the devices immediately instead of returning them to the manufacturer. 
READ MORE >

Stroke risk after TAVR still higher for woman as ‘sex paradox’ lives on

By tracking sex-related differences after TAVR, researchers hope to refine patient selection strategies and optimize care for both men and women.

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a patient talks with her doctor, both are women of color
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Stroke risk after TAVR still higher for woman as ‘sex paradox’ lives on

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a patient talks with her doctor, both are women of color
By tracking sex-related differences after TAVR, researchers hope to refine patient selection strategies and optimize care for both men and women.
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ECG market keeps evolving thanks to AI, home monitoring and Epic integration

For years, the ECG market was relatively static. According to a new report, however, things are rapidly changing. 

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The HeartBeam AIMIGo device is approximately the size of a credit card and uses the company’s patented 3D vectorelectrocardiography (3D VECG) technology to capture signals from three different projections and deliver a synthesized 12-lead ECG.
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ECG market keeps evolving thanks to AI, home monitoring and Epic integration

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The HeartBeam AIMIGo device is approximately the size of a credit card and uses the company’s patented 3D vectorelectrocardiography (3D VECG) technology to capture signals from three different projections and deliver a synthesized 12-lead ECG.
For years, the ECG market was relatively static. According to a new report, however, things are rapidly changing. 
READ MORE >

Blood glucose monitor instructions updated due to error code linked to 114 injuries

No devices need to be returned or replaced, but the company did want to update their instructions for use. 

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Trividia Health True Metrix
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Blood glucose monitor instructions updated due to error code linked to 114 injuries

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Trividia Health True Metrix
No devices need to be returned or replaced, but the company did want to update their instructions for use. 
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New initiative to fund pulmonary embolism research

Grants from $50,000 to $750,000 will be awarded to pay for physician-led studies focused on PE care.

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Example of spectral, or dual-energy CT, confirming a pulmonary embolism (PE). Image courtesy of Philips Healthcare
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New initiative to fund pulmonary embolism research

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Example of spectral, or dual-energy CT, confirming a pulmonary embolism (PE). Image courtesy of Philips Healthcare
Grants from $50,000 to $750,000 will be awarded to pay for physician-led studies focused on PE care.
READ MORE >

Featured Articles

Impella use fails to improve mortality in elderly patients

The Impella CP heart pump is being used more and more to treat cardiogenic shock, and the benefits are clear. For many older patients, however, the technology seem to fall short. 

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Andres Cordova, MD, cardiology fellow, University of Vermont Medical Center, explains a study of registry and outcomes data on the use of Impella hemodynamic support in elderly STEMI patients with cardiogenic shock.
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Impella use fails to improve mortality in elderly patients

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Andres Cordova, MD, cardiology fellow, University of Vermont Medical Center, explains a study of registry and outcomes data on the use of Impella hemodynamic support in elderly STEMI patients with cardiogenic shock.
The Impella CP heart pump is being used more and more to treat cardiogenic shock, and the benefits are clear. For many older patients, however, the technology seem to fall short. 
READ MORE >

Boston EP Party: Medtech companies share new electrophysiology data at AF Symposium 2026

AF Symposium 2026 in Boston included new data from some of the biggest names in electrophysiology. Johnson & Johnson MedTech, Abbott, Atraverse Medical, Field Medical, Pulse Biosciences, Argá Medtech SA and CardioFocus were just some of the medtech companies at the heart of late-breaking presentations. 

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Boston, the home of AF Symposium 2026
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Boston EP Party: Medtech companies share new electrophysiology data at AF Symposium 2026

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Boston, the home of AF Symposium 2026
AF Symposium 2026 in Boston included new data from some of the biggest names in electrophysiology. Johnson & Johnson MedTech, Abbott, Atraverse Medical, Field Medical, Pulse Biosciences, Argá Medtech SA and CardioFocus were just some of the medtech companies at the heart of late-breaking presentations. 
READ MORE >

Safety update: New recommendations for managing patients with high-risk defibrillation leads

HRS has shared an updated guidance on managing Boston Scientific defibrillation leads at risk of experiencing a significant malfunction. The issue, first reported in July 2025, is believed to impact approximately 350,000 leads still being used today.

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warning safety alert recall healthcare issue
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Safety update: New recommendations for managing patients with high-risk defibrillation leads

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warning safety alert recall healthcare issue
HRS has shared an updated guidance on managing Boston Scientific defibrillation leads at risk of experiencing a significant malfunction. The issue, first reported in July 2025, is believed to impact approximately 350,000 leads still being used today.
READ MORE >

In Case You Missed It

Confirmed: Mediterranean diet helps heart patients live longer, healthier lives

The diet, named after the traditional eating habits of Greece and Italy, is already known for its benefits to the general public. Its impact on heart patients, however, was less clear. 

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Mediterranean diet keto diet
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Confirmed: Mediterranean diet helps heart patients live longer, healthier lives

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Mediterranean diet keto diet
The diet, named after the traditional eating habits of Greece and Italy, is already known for its benefits to the general public. Its impact on heart patients, however, was less clear. 
READ MORE >

AI agent calling cath lab patients to help them prepare for treatment

Mount Sinai Hospital in New York is now using AI-powered virtual agents to call some patients before cath lab procedures. The move was designed to help nurses focus more on patient care and reduce their risk of burnout.

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Andriy Vengrenyuk, MS, senior data analyst for interventional cardiology at the Icahn School of Medicine at Mount Sinai, explains a pilot program where artificial intelligence (AI) virtual agents call patients prior to their cath lab procedures to save nursing staff time doing administrative tasks.
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AI agent calling cath lab patients to help them prepare for treatment

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Andriy Vengrenyuk, MS, senior data analyst for interventional cardiology at the Icahn School of Medicine at Mount Sinai, explains a pilot program where artificial intelligence (AI) virtual agents call patients prior to their cath lab procedures to save nursing staff time doing administrative tasks.
Mount Sinai Hospital in New York is now using AI-powered virtual agents to call some patients before cath lab procedures. The move was designed to help nurses focus more on patient care and reduce their risk of burnout.
READ MORE >

Treating CLTI with atherectomy fails to improve outcomes—is it worth the cost?

Atherectomy is associated with rising healthcare costs, making it important to learn as much about the procedure's long-term value as possible. 

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doctor looking at CLTI patient's leg
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Treating CLTI with atherectomy fails to improve outcomes—is it worth the cost?

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doctor looking at CLTI patient's leg
Atherectomy is associated with rising healthcare costs, making it important to learn as much about the procedure's long-term value as possible. 
READ MORE >

In Other News

Patients cite prior authorization as top healthcare burden, KFF finds

In a new poll, more insured adults listed receiving coverage approval for treatment and medications as the single largest burden they face when navigating the U.S. healthcare system than any other issue. KFF found that 47% experienced “denied, delayed or altered” patient care over the last two years. 

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insurance insurer payment claim denial reimbursement prior authorization
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Patients cite prior authorization as top healthcare burden, KFF finds

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insurance insurer payment claim denial reimbursement prior authorization
In a new poll, more insured adults listed receiving coverage approval for treatment and medications as the single largest burden they face when navigating the U.S. healthcare system than any other issue. KFF found that 47% experienced “denied, delayed or altered” patient care over the last two years. 
READ MORE >

5 takeaways from Dr. Wachter’s ‘Giant Leap’ with AI in healthcare

Someday the computerization of medicine will be recognized as the game-changing, paradigm-shifting, everything-upending “disruptive innovation” that so many healthcare watchers and stakeholders have been waiting for. “Today,” however, “it’s often just plain disruptive.”

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Robert Wachter MD
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5 takeaways from Dr. Wachter’s ‘Giant Leap’ with AI in healthcare

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Robert Wachter MD
Someday the computerization of medicine will be recognized as the game-changing, paradigm-shifting, everything-upending “disruptive innovation” that so many healthcare watchers and stakeholders have been waiting for. “Today,” however, “it’s often just plain disruptive.”
READ MORE >

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