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The potential impact of ablations being performed in ASCs | A key DanGer Shock update | FDA clears new robotic system

News You Need to Know Today
The potential impact of ablations being performed in ASCs | A key DanGer Shock update | FDA clears new robotic system
Tuesday, September 9, 2025
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Today's News and Trends

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. 
READ MORE >

DanGer Shock update: Impella CP heart pump linked to long-term survival benefit

When patients present with STEMI-related cardiogenic shock, treatment with the Impella CP appears to make a positive impact that lasts for at least a decade.

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The key figure from NEJM publication confirms the survival benefit of Impella CP increases year-over-year. Source: Møller J, et al. Long Term Outcomes of the DanGer Shock Trial. N Engl J Med 2025.
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DanGer Shock update: Impella CP heart pump linked to long-term survival benefit

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The key figure from NEJM publication confirms the survival benefit of Impella CP increases year-over-year. Source: Møller J, et al. Long Term Outcomes of the DanGer Shock Trial. N Engl J Med 2025.
When patients present with STEMI-related cardiogenic shock, treatment with the Impella CP appears to make a positive impact that lasts for at least a decade.
READ MORE >

FDA clears single-use, fully disposable endovascular robotic system

The new Liberty System allows users to remotely deliver and manipulate guidewires and catheters during peripheral endovascular procedures.

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Microbot Medical Liberty
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FDA clears single-use, fully disposable endovascular robotic system

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Microbot Medical Liberty
The new Liberty System allows users to remotely deliver and manipulate guidewires and catheters during peripheral endovascular procedures.
READ MORE >

Featured Articles

Update: FDA announces new Class I recalls due to safety issue with Medtronic catheters

More than 100,000 surgical devices are included in these recalls, and there may be "limited product availability" in the months ahead. The FDA first warned the public about this issue in August. 

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the words "FDA recall" on a board
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Update: FDA announces new Class I recalls due to safety issue with Medtronic catheters

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the words "FDA recall" on a board
More than 100,000 surgical devices are included in these recalls, and there may be "limited product availability" in the months ahead. The FDA first warned the public about this issue in August. 
READ MORE >

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 >

Advances in electrosurgical techniques have helped thousands of transcatheter valve patients

Toby Rogers, MD, associate professor of medicine at Georgetown University and an interventional cardiologist at MedStar, explains how electrosurgical procedures for transcaval access have helped large numbers of patients receive transcatheter heart valves who otherwise would have been disqualified due to anatomical issues. 
 

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Toby Rogers, MD, PhD, associate professor of medicine Georgetown University, and interventional cardiologist at MedStar Heart and Vascular Institute Structural Heart Disease program, explains how the transcatheter electrosurgical procedures for transcaval access, SESAME, LAMPOON and BASILICA has helped large numbers of patients receive transcatheter heart valves who otherwise would have been disqualified due to anatomical issues.
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Advances in electrosurgical techniques have helped thousands of transcatheter valve patients

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Toby Rogers, MD, PhD, associate professor of medicine Georgetown University, and interventional cardiologist at MedStar Heart and Vascular Institute Structural Heart Disease program, explains how the transcatheter electrosurgical procedures for transcaval access, SESAME, LAMPOON and BASILICA has helped large numbers of patients receive transcatheter heart valves who otherwise would have been disqualified due to anatomical issues.
Toby Rogers, MD, associate professor of medicine at Georgetown University and an interventional cardiologist at MedStar, explains how electrosurgical procedures for transcaval access have helped large numbers of patients receive transcatheter heart valves who otherwise would have been disqualified due to anatomical issues.  
READ MORE >

FDA clears GE Revolution Vibe CT scanner aimed at rapidly growing CCTA market

“FDA clearance comes at the perfect time, with guidelines being adopted clinically for cardiac CT and with positive reimbursement driving procedure growth," says Jean-Luc Procaccini, CEO, molecular imaging and CT.

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GE HealthCare recently received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Revolution Vibe CT system, which the company said is squarely aimed at the rapidly growing coronary computed tomography angiography (CCTA) market.
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FDA clears GE Revolution Vibe CT scanner aimed at rapidly growing CCTA market

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GE HealthCare recently received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Revolution Vibe CT system, which the company said is squarely aimed at the rapidly growing coronary computed tomography angiography (CCTA) market.
“FDA clearance comes at the perfect time, with guidelines being adopted clinically for cardiac CT and with positive reimbursement driving procedure growth," says Jean-Luc Procaccini, CEO, molecular imaging and CT.
READ MORE >

In Case You Missed It

Cardiology practices must be more sustainable to survive

Cardiology faces one of its most challenging decades ahead, with mounting pressures from workforce shortages, an aging population and declining reimbursements. To remain sustainable, practices are forced to rethink how care is delivered from the ground up.

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Geoffrey Rose, MD, president of Sanger Heart and Vascular Institute, discusses how to manage a sustainable cardiology practice in the coming decade and what challenges are involved.
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Cardiology practices must be more sustainable to survive

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Geoffrey Rose, MD, president of Sanger Heart and Vascular Institute, discusses how to manage a sustainable cardiology practice in the coming decade and what challenges are involved.
Cardiology faces one of its most challenging decades ahead, with mounting pressures from workforce shortages, an aging population and declining reimbursements. To remain sustainable, practices are forced to rethink how care is delivered from the ground up.
READ MORE >

Nuclear imaging company Positron moves to New York for ‘exciting new chapter’

Positron made the move to help its case when it files an official Form 10 registration statement with the SEC.

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Positron NeuSight PET-CT 64 slice scanner
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Nuclear imaging company Positron moves to New York for ‘exciting new chapter’

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Positron NeuSight PET-CT 64 slice scanner
Positron made the move to help its case when it files an official Form 10 registration statement with the SEC.
READ MORE >

Boston Scientific launches study comparing drug-coated balloons to standard care

"This important study will evaluate the potential benefits of the AGENT DCB for patients with certain anatomical features in de novo coronary lesions, where the avoidance of stents is preferable to help circumvent potential complications,” said Janar Sathananthan, MD, chief medical officer, interventional cardiology therapies, Boston Scientific. 

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Boston Scientific said it initiated the AGENT DCB STANCE trial to assess the safety and effectiveness of the Agent Drug-Coated Balloon (DCB) compared to the standard of care using either percutaneous coronary intervention (PCI) with drug-eluting stents (DES) and/or balloon angioplasty. The trial will enroll more than 1,600 patients and is expected to a primary completion date in 2028.
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Boston Scientific launches study comparing drug-coated balloons to standard care

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Boston Scientific said it initiated the AGENT DCB STANCE trial to assess the safety and effectiveness of the Agent Drug-Coated Balloon (DCB) compared to the standard of care using either percutaneous coronary intervention (PCI) with drug-eluting stents (DES) and/or balloon angioplasty. The trial will enroll more than 1,600 patients and is expected to a primary completion date in 2028.
"This important study will evaluate the potential benefits of the AGENT DCB for patients with certain anatomical features in de novo coronary lesions, where the avoidance of stents is preferable to help circumvent potential complications,” said Janar Sathananthan, MD, chief medical officer, interventional cardiology therapies, Boston Scientific. 
READ MORE >

In Other News

Healthcare AI today: Healthcare AI on Capitol Hill, hospital leadership’s eye on AI, publicly traded AI recalls, more

AI could appreciably improve the delivery of healthcare services to patients—if only people trusted it. For many, the difference-maker would be nicely crafted federal regulations. 

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house of representatives hearing AI in healthcare
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Healthcare AI today: Healthcare AI on Capitol Hill, hospital leadership’s eye on AI, publicly traded AI recalls, more

Share on Twitter Share on Facebook Share on Linkedin
house of representatives hearing AI in healthcare
AI could appreciably improve the delivery of healthcare services to patients—if only people trusted it. For many, the difference-maker would be nicely crafted federal regulations. 
READ MORE >

Ultrasound guidance safer, more effective for biopsies of peripheral lung lesions in pediatric patients

The technique has proven effective in adults, but until recently there has been a lack of data on its use among children.

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Ultrasound guidance a safer, more accurate method for biopsies of peripheral lung lesions in children
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Ultrasound guidance safer, more effective for biopsies of peripheral lung lesions in pediatric patients

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Ultrasound guidance a safer, more accurate method for biopsies of peripheral lung lesions in children
The technique has proven effective in adults, but until recently there has been a lack of data on its use among children.
READ MORE >

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