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News You Need to Know Today
A safety update for cardiologists | AF Symposium 2026 | Catheters recalled | Nasal spray for PSVT | Key FDA approvals
Tuesday, February 10, 2026
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Editor's Choice: Heart Rhythm

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 >

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. 
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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. 
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FDA clears AI software for heart murmur detection with digital stethoscopes

eMurmer's new Heart AI software was designed to detect both the presence and absence of heart murmurs in digital stethoscope recordings. It can also gather critical hemodynamic data, helping care teams gain a better understanding of the patient's cardiovascular health. 

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eMurmur Heart AI
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FDA clears AI software for heart murmur detection with digital stethoscopes

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eMurmur Heart AI
eMurmer's new Heart AI software was designed to detect both the presence and absence of heart murmurs in digital stethoscope recordings. It can also gather critical hemodynamic data, helping care teams gain a better understanding of the patient's cardiovascular health. 
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Nasal spray for paroxysmal supraventricular tachycardia enters US market

New drug allows patients to self-treat PSVT. About 2 million people in the U.S. have been diagnosed with condition.

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New data from the Phase 3 RAPID clinical trial of etripamil, an investigational calcium channel blocker nasal spray, showed positive results in converting paroxysmal supraventricular tachycardia (PSVT) to normal sinus rhythm in the at-home setting. The presentation was featured during a late-breaking clinical trials session at the American Heart Association (AHA) 2022 Scientific Sessions. #AHA22
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Nasal spray for paroxysmal supraventricular tachycardia enters US market

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New data from the Phase 3 RAPID clinical trial of etripamil, an investigational calcium channel blocker nasal spray, showed positive results in converting paroxysmal supraventricular tachycardia (PSVT) to normal sinus rhythm in the at-home setting. The presentation was featured during a late-breaking clinical trials session at the American Heart Association (AHA) 2022 Scientific Sessions. #AHA22
New drug allows patients to self-treat PSVT. About 2 million people in the U.S. have been diagnosed with condition.
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FDA-approved PFA system linked to positive 1-year data, ‘impeccable’ durability

The Globe Pulsed Field System, which secured FDA approval in September 2025, features high-density mapping capabilities and a 122-electrode spherical array.

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Kardium, a Canadian medical device company focused on electrophysiology technologies, has raised $104 million in new financing. mages of the Globe Pulsed Field System courtesy of Kardium
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FDA-approved PFA system linked to positive 1-year data, ‘impeccable’ durability

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Kardium, a Canadian medical device company focused on electrophysiology technologies, has raised $104 million in new financing. mages of the Globe Pulsed Field System courtesy of Kardium
The Globe Pulsed Field System, which secured FDA approval in September 2025, features high-density mapping capabilities and a 122-electrode spherical array.
READ MORE >

FDA clears MRI-compatible EP mapping catheter

This represents the first FDA clearance for Imricor Medical Systems. "It’s an exciting achievement and a date to be noted and remembered," CEO Steve Wedan said in a statement. 

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Vision-MR Diagnostic Catheter
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FDA clears MRI-compatible EP mapping catheter

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Vision-MR Diagnostic Catheter
This represents the first FDA clearance for Imricor Medical Systems. "It’s an exciting achievement and a date to be noted and remembered," CEO Steve Wedan said in a statement. 
READ MORE >

Abbott works with AtaCor Medical on extravascular ICD system

Extravascular ICDs were developed to avoid complications such as vascular injuries, lead fractures and lead infections. Although rare, these issues can cause serious, life-threatening complications for patients.

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Abbott recently announced it is partnering with AtaCor Medical to develop a next-generation extravascular implantable cardioverter defibrillator (EV-ICD) system. AtaCor's investigational extravascular ICD lead will be paired with Abbott's investigational extravascular ICD system.
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Abbott works with AtaCor Medical on extravascular ICD system

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Abbott recently announced it is partnering with AtaCor Medical to develop a next-generation extravascular implantable cardioverter defibrillator (EV-ICD) system. AtaCor's investigational extravascular ICD lead will be paired with Abbott's investigational extravascular ICD system.
Extravascular ICDs were developed to avoid complications such as vascular injuries, lead fractures and lead infections. Although rare, these issues can cause serious, life-threatening complications for patients.
READ MORE >

Medtronic’s newest all-in-one PFA catheter gains critical approval

The all-in-one mapping and single-shot PFA catheter was developed with electrophysiologist feedback in mind. 

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Medtronic has secured CE mark approval for its Affera Sphere-360 catheter,
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Medtronic’s newest all-in-one PFA catheter gains critical approval

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Medtronic has secured CE mark approval for its Affera Sphere-360 catheter,
The all-in-one mapping and single-shot PFA catheter was developed with electrophysiologist feedback in mind. 
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Abbott secures key approval for new catheter capable of PFA, radiofrequency ablation

The TactiFlex Duo Ablation Catheter, Sensor Enabled was designed to switch from PFA to radiofrequency ablation as needed, providing electrophysiologists with options when treating AFib patients.

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TactiFlex Duo Ablation Catheter, Sensor Enabled
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Abbott secures key approval for new catheter capable of PFA, radiofrequency ablation

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TactiFlex Duo Ablation Catheter, Sensor Enabled
The TactiFlex Duo Ablation Catheter, Sensor Enabled was designed to switch from PFA to radiofrequency ablation as needed, providing electrophysiologists with options when treating AFib patients.
READ MORE >

FDA approves Boston Scientific’s Farapoint PFA catheter

The newest addition to the company's Farapulse PFA Platform was specifically approved to perform cavotricuspid isthmus ablation. 

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Boston Scientific Farapoint pulsed field ablation (PFA) catheter
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FDA approves Boston Scientific’s Farapoint PFA catheter

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Boston Scientific Farapoint pulsed field ablation (PFA) catheter
The newest addition to the company's Farapulse PFA Platform was specifically approved to perform cavotricuspid isthmus ablation. 
READ MORE >

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