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News You Need to Know Today
CMS proposes performing cardiac ablations at ASCs | A warning from Abbott | Defibrillation leads recalled | LVDF & AFib
Friday, September 19, 2025
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Editor's Choice: Heart Rhythm

Q&A: Cardiologist explores CMS proposal to cover cardiac ablations performed in ambulatory surgical centers

CMS has proposed a policy shift that would allow cardiac ablation procedures to be performed in ambulatory surgical centers. Arash Aryana, MD, PhD, a veteran cardiac electrophysiologist, explained why he is "extremely encouraged" by this proposal, highlighting several potential benefits. 

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Newsweek ranked the 50 best heart hospitals in the world
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Q&A: Cardiologist explores CMS proposal to cover cardiac ablations performed in ambulatory surgical centers

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Newsweek ranked the 50 best heart hospitals in the world
CMS has proposed a policy shift that would allow cardiac ablation procedures to be performed in ambulatory surgical centers. Arash Aryana, MD, PhD, a veteran cardiac electrophysiologist, explained why he is "extremely encouraged" by this proposal, highlighting several potential benefits. 
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Abbott warns EP labs the tip can detach from its TactiFlex ablation catheters

Improper removal of the catheter from the packaging can result in tip damage. Most damaged tips were detected prior to being used, but three tips did separate inside patients.
 

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Abbott has recalled its TactiFlex Ablation Catheter, Sensor Enabled, because of reports that the tip can separate.
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Abbott warns EP labs the tip can detach from its TactiFlex ablation catheters

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Abbott has recalled its TactiFlex Ablation Catheter, Sensor Enabled, because of reports that the tip can separate.
Improper removal of the catheter from the packaging can result in tip damage. Most damaged tips were detected prior to being used, but three tips did separate inside patients. 
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Update: FDA confirms recalls for defibrillation leads after nearly 400 injuries

Safety concerns with certain Boston Scientific leads have resulted in multiple Class I recalls, the FDA has announced. The agency first shared a warning about this issue in August. 

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Recall | Product recall
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Update: FDA confirms recalls for defibrillation leads after nearly 400 injuries

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Recall | Product recall
Safety concerns with certain Boston Scientific leads have resulted in multiple Class I recalls, the FDA has announced. The agency first shared a warning about this issue in August. 
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PFA linked to increased risk of phrenic nerve damage

“We believe that any iatrogenic complication should be reported,” the study's authors wrote. “No patient expects to be discharged from hospital with a new diaphragmatic deficit without being informed."

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The Farapulse Boston Scientific Pulsed Field Ablation (PFA) system gained U.S. FDA approval in early 2024.
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PFA linked to increased risk of phrenic nerve damage

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The Farapulse Boston Scientific Pulsed Field Ablation (PFA) system gained U.S. FDA approval in early 2024.
“We believe that any iatrogenic complication should be reported,” the study's authors wrote. “No patient expects to be discharged from hospital with a new diaphragmatic deficit without being informed."
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Boston Scientific to purchase Elutia’s drug-eluting envelope business for $88M

The FDA-cleared EluPro bioenvelope delivers two antibiotics to patients over an extended period of time after they receive an implantable pacemaker or defibrillator to cut infection rates.

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money business cash flow dollar. Kingsway Financial Services, a Chicago-based holding company with subsidiaries in several industries, has acquired New Jersey-based Digital Diagnostics Imaging (DDI) for $11 million. The transaction was funded with $5.4 million in cash and $5.6 million in debt financing.
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Boston Scientific to purchase Elutia’s drug-eluting envelope business for $88M

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money business cash flow dollar. Kingsway Financial Services, a Chicago-based holding company with subsidiaries in several industries, has acquired New Jersey-based Digital Diagnostics Imaging (DDI) for $11 million. The transaction was funded with $5.4 million in cash and $5.6 million in debt financing.
The FDA-cleared EluPro bioenvelope delivers two antibiotics to patients over an extended period of time after they receive an implantable pacemaker or defibrillator to cut infection rates.
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Exploring the link between left ventricular diastolic function and AFib

Evaluating LVDF with echocardiography or AI-powered electrocardiography can help identify individuals at an increased risk of developing atrial fibrillation, according to new data presented at the ASE 36th Annual Scientific Sessions.

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Agfa patient time line of prior exams and echo reporting in its CVIS at ASE 2023.
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Exploring the link between left ventricular diastolic function and AFib

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Agfa patient time line of prior exams and echo reporting in its CVIS at ASE 2023.
Evaluating LVDF with echocardiography or AI-powered electrocardiography can help identify individuals at an increased risk of developing atrial fibrillation, according to new data presented at the ASE 36th Annual Scientific Sessions.
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FDA clears Kardium Globe pulsed field ablation system

It is the only integrated system that combines high-density mapping and PFA in a single device. The system uses a 122-electrode spherical array to enable rapid, single-shot pulmonary vein isolation, helping to streamline workflows.

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The U.S. Food and Drug Administration (FDA) has granted pre-market approval (PMA) for the Globe Pulsed Field Ablation (PFA) System, and 510(k) clearance for both the Globe introducer sheath and the Globe Pulsed Field System mapping software from Kardium Inc. This add another competitor in the growing U.S. PFA market to treat atrial fibrillation (AFib).
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FDA clears Kardium Globe pulsed field ablation system

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The U.S. Food and Drug Administration (FDA) has granted pre-market approval (PMA) for the Globe Pulsed Field Ablation (PFA) System, and 510(k) clearance for both the Globe introducer sheath and the Globe Pulsed Field System mapping software from Kardium Inc. This add another competitor in the growing U.S. PFA market to treat atrial fibrillation (AFib).
It is the only integrated system that combines high-density mapping and PFA in a single device. The system uses a 122-electrode spherical array to enable rapid, single-shot pulmonary vein isolation, helping to streamline workflows.
READ MORE >

First commercial robotically navigated, high-density EP mapping procedures performed in US

The Stereotaxis MAGiC Sweep gained FDA clearance in July and its first commercial use was announced this week.

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Stereotaxis MAGIC SWEEP electrophysiology catheter
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First commercial robotically navigated, high-density EP mapping procedures performed in US

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Stereotaxis MAGIC SWEEP electrophysiology catheter
The Stereotaxis MAGiC Sweep gained FDA clearance in July and its first commercial use was announced this week.
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Philips launches smart telemetry platform for cardiac monitoring

Care teams can face alarm and cognitive overload, with an average of 350 alarms going off per patient per day. But Philips' new telemetry platform streamlines alarm management, delivers data-driven insights and automates clinical tasks—with operational simplicity and networking options.

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Philips introduced a new cardiac monitoring telemetry platform designed to help address critical challenges in healthcare, including staff shortages and alarm management. A key component of the solution is the next-generation Telemetry Monitor 5500 is an integrated central monitoring unit solution that integrates the telemetry device platform.
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Philips launches smart telemetry platform for cardiac monitoring

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Philips introduced a new cardiac monitoring telemetry platform designed to help address critical challenges in healthcare, including staff shortages and alarm management. A key component of the solution is the next-generation Telemetry Monitor 5500 is an integrated central monitoring unit solution that integrates the telemetry device platform.
Care teams can face alarm and cognitive overload, with an average of 350 alarms going off per patient per day. But Philips' new telemetry platform streamlines alarm management, delivers data-driven insights and automates clinical tasks—with operational simplicity and networking options.
READ MORE >

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