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News You Need to Know Today
FDA clears new AI-enabled CCTA scanner | New PFA catheter integrates high-density mapping | Electrosurgical cuts boost TAVR
Monday, September 8, 2025
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Today's News and Trends

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

Share on Twitter Share on Facebook Share on Linkedin
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 >

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 >

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 >

Featured Articles

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 >

3D echo guidance seeing increasing use in congenital heart surgery

Pei-Ni Jone, MD, FASE, director, echocardiography laboratory, Lurie Children’s Hospital Heart Center, member of the American Society of Echocardiography (ASE) Board, explains how 3D echo is being used to better plan, guide and follow up in congenital cardiac surgery.

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Pei-Ni Jone, MD, FASE, director, echocardiography laboratory, Lurie Children’s Hospital Heart Center, professor of pediatric cardiology, Northwestern University Feinberg School of Medicine, member of the American Society of Echocardiography (ASE) Board, and the chair of the ASE Pediatric and Congenital Heart Disease Council Steering Committee, explains how 3D echo is being used to better plan, guide and followup in congenital cardiac surgery.
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3D echo guidance seeing increasing use in congenital heart surgery

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Pei-Ni Jone, MD, FASE, director, echocardiography laboratory, Lurie Children’s Hospital Heart Center, professor of pediatric cardiology, Northwestern University Feinberg School of Medicine, member of the American Society of Echocardiography (ASE) Board, and the chair of the ASE Pediatric and Congenital Heart Disease Council Steering Committee, explains how 3D echo is being used to better plan, guide and followup in congenital cardiac surgery.
Pei-Ni Jone, MD, FASE, director, echocardiography laboratory, Lurie Children’s Hospital Heart Center, member of the American Society of Echocardiography (ASE) Board, explains how 3D echo is being used to better plan, guide and follow up in congenital cardiac surgery.
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.
READ MORE >

How to address CCTA staffing shortages

Jaime Warren, EdD, FACC, vice president of care transformation at MedAxiom, an ACC company, explains what is needed to address staffing shortages created by a 94% increase in cardiac CT volumes over the past 5 years. 

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Jaime Warren, EdD, FACC, vice president of care transformation at MedAxiom, an ACC company, explains what is needed to address staffing shortages created by a 94% increase in cardiac CT volumes over the past 5 years.
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How to address CCTA staffing shortages

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Jaime Warren, EdD, FACC, vice president of care transformation at MedAxiom, an ACC company, explains what is needed to address staffing shortages created by a 94% increase in cardiac CT volumes over the past 5 years.
Jaime Warren, EdD, FACC, vice president of care transformation at MedAxiom, an ACC company, explains what is needed to address staffing shortages created by a 94% increase in cardiac CT volumes over the past 5 years. 
READ MORE >

FDA clears first large-bore, vacuum-assisted pulmonary embolism thrombectomy system

The Symphony Thrombectomy System eliminates tradeoffs between two priorities—leveraging large-bore power and ease of use vs. efficiently reducing clot burden and delivering improved speed. 

 

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The U.S. Food and Drug Administration (FDA) granted 510(k) clearance for the first large-bore continuous vacuum-assisted system to treat pulmonary embolism (PE). The Symphony Thrombectomy System from Imperative Care Inc. enables physicians to remove more clot from the lungs in less time.
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FDA clears first large-bore, vacuum-assisted pulmonary embolism thrombectomy system

Share on Twitter Share on Facebook Share on Linkedin
The U.S. Food and Drug Administration (FDA) granted 510(k) clearance for the first large-bore continuous vacuum-assisted system to treat pulmonary embolism (PE). The Symphony Thrombectomy System from Imperative Care Inc. enables physicians to remove more clot from the lungs in less time.
The Symphony Thrombectomy System eliminates tradeoffs between two priorities—leveraging large-bore power and ease of use vs. efficiently reducing clot burden and delivering improved speed.  
READ MORE >

ESC Congress broke new record with over 33,000 attendees

The European Society of Cardiology had nearly twice as many attendees as ACC this year, as the European meeting secures its place as the largest cardiology meeting in the world.

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The European Society of Cardiology (ESC) annual congress has become the largest cardiology in the world with more than 33,000 healthcare professionals at the 2025 meeting. Photo by ESC
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ESC Congress broke new record with over 33,000 attendees

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The European Society of Cardiology (ESC) annual congress has become the largest cardiology in the world with more than 33,000 healthcare professionals at the 2025 meeting. Photo by ESC
The European Society of Cardiology had nearly twice as many attendees as ACC this year, as the European meeting secures its place as the largest cardiology meeting in the world.
READ MORE >

In Other News

Kneecapping National Institutes of Health will stifle economic growth, radiology groups warn

Over 500 healthcare organizations including the ACR issued their plea as Congress considers 2026 funding for the key federal agency. 

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National Institutes of Health NIH
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Kneecapping National Institutes of Health will stifle economic growth, radiology groups warn

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National Institutes of Health NIH
Over 500 healthcare organizations including the ACR issued their plea as Congress considers 2026 funding for the key federal agency. 
READ MORE >

Is AI in healthcare a massive money pit? Maybe, maybe not.

It’s too soon to characterize the economic impact of AI across Western healthcare with anything more than rough guesstimates. This is so for two reasons. 

READ MORE >
healthcare ai artificial intelligence economics
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Is AI in healthcare a massive money pit? Maybe, maybe not.

Share on Twitter Share on Facebook Share on Linkedin
healthcare ai artificial intelligence economics
It’s too soon to characterize the economic impact of AI across Western healthcare with anything more than rough guesstimates. This is so for two reasons. 
READ MORE >

HHS restoring deleted health information following legal challenge

A trove of content and data studies was purged from federal websites in an effort to eliminate “diversity, equity and inclusion.” That sweep also removed facts on maternal health, opioid addiction and more, leading to multiple lawsuits. One has now been settled.

READ MORE >
Woke DEI
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HHS restoring deleted health information following legal challenge

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Woke DEI
A trove of content and data studies was purged from federal websites in an effort to eliminate “diversity, equity and inclusion.” That sweep also removed facts on maternal health, opioid addiction and more, leading to multiple lawsuits. One has now been settled.
READ MORE >

Hackers inside hospital network for two months expose 140K people

Aspire Rural Health System, a three-hospital system in Michigan, said it was unaware that its network had been compromised. An investigation revealed that hackers gained access to protected health information, including patient charts. 

READ MORE >
cybersecurity hacker ransomware cyber data breach
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Hackers inside hospital network for two months expose 140K people

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cybersecurity hacker ransomware cyber data breach
Aspire Rural Health System, a three-hospital system in Michigan, said it was unaware that its network had been compromised. An investigation revealed that hackers gained access to protected health information, including patient charts. 
READ MORE >

Report: HHS suppresses major study that found link between alcohol and cancer

Speaking to Vox, the authors said they were informed the results of their major study commissioned by the Department of Health and Human Services (HHS) would not be published. However, there appeared to be nothing wrong with the methodology of the analysis.

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alcoholshotdrink.jpg
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Report: HHS suppresses major study that found link between alcohol and cancer

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alcoholshotdrink.jpg
Speaking to Vox, the authors said they were informed the results of their major study commissioned by the Department of Health and Human Services (HHS) would not be published. However, there appeared to be nothing wrong with the methodology of the analysis.
READ MORE >

New partnership seeks to increase imaging departments' remote-scanning capabilities

Many organizations are interested in remote scanning as a means of addressing ongoing technologist staffing shortages.

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remote work from home telecommute
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New partnership seeks to increase imaging departments' remote-scanning capabilities

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remote work from home telecommute
Many organizations are interested in remote scanning as a means of addressing ongoing technologist staffing shortages.
READ MORE >

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