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News You Need to Know Today
Catheters recalled over health risks | Improved reimbursement | Medtronic recalls software | Cardiology: Empowering or stifling?
Monday, December 1, 2025
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Today's News and Trends

Catheters recalled due to defect—FDA highlights risk of stroke or brain damage

The recall was put in place after a hydrophilic coating was discovered on the inside of the devices. According to the FDA, patients treated with the catheters could face a number of significant risks. 

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Product Recall
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Catheters recalled due to defect—FDA highlights risk of stroke or brain damage

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Product Recall
The recall was put in place after a hydrophilic coating was discovered on the inside of the devices. According to the FDA, patients treated with the catheters could face a number of significant risks. 
READ MORE >

Reimbursement for AI-based plaque assessments is improving

A growing number of private insurers are now covering these advanced technologies. Roosha Parikh, MD, told Cardiovascular Business that the hard work of SCCT and other groups has helped make this happen. 

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The Society of Cardiovascular Computed Tomography (SCCT) is seeing major progress in its long-running push to secure broad reimbursement for artificial intelligence (AI)-enabled coronary CT angiography (CCTA) plaque analysis. According to Roosha Parikh, MD, FACC, FSCCT, associate director of Cardiac CT at St. Francis Heart Hospital, Long Island, New York, and a member of the SCCT Health Policy and Practice Committee, both Medicare and a growing number of private insurers are now covering the technology.
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Reimbursement for AI-based plaque assessments is improving

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The Society of Cardiovascular Computed Tomography (SCCT) is seeing major progress in its long-running push to secure broad reimbursement for artificial intelligence (AI)-enabled coronary CT angiography (CCTA) plaque analysis. According to Roosha Parikh, MD, FACC, FSCCT, associate director of Cardiac CT at St. Francis Heart Hospital, Long Island, New York, and a member of the SCCT Health Policy and Practice Committee, both Medicare and a growing number of private insurers are now covering the technology.
A growing number of private insurers are now covering these advanced technologies. Roosha Parikh, MD, told Cardiovascular Business that the hard work of SCCT and other groups has helped make this happen. 
READ MORE >

Medtronic recalls data management software, urging healthcare providers to run update

The error caused incorrect glucose data to be displayed to clinicians. According to Medtronic, any treatment decisions or recommendations based on those data need to be revisited.

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Medtronic recalls data management software, urging healthcare providers to run update

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The error caused incorrect glucose data to be displayed to clinicians. According to Medtronic, any treatment decisions or recommendations based on those data need to be revisited.
READ MORE >

Is the field of cardiology empowering or stifling? Cardiologists share their perspective

Some cardiologists feel the specialty is inclusive and nothing needs to change, but not everyone agrees with that sentiment. A new survey detailed the perspective of more than 1,500 cardiologists. 

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female cardiologist
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Is the field of cardiology empowering or stifling? Cardiologists share their perspective

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female cardiologist
Some cardiologists feel the specialty is inclusive and nothing needs to change, but not everyone agrees with that sentiment. A new survey detailed the perspective of more than 1,500 cardiologists. 
READ MORE >

Featured Articles

Abbott shares safety concerns with millions of CGM sensors—7 deaths reported

Approximately 3 million FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors need to be replaced due to a risk of incorrect glucose readings. Abbott has received reports of 736 severe adverse events and seven deaths that may be related to this issue.

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Abbott’s FreeStyle Libre 3 integrated continuous glucose monitoring (iCGM) system.
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Abbott shares safety concerns with millions of CGM sensors—7 deaths reported

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Abbott’s FreeStyle Libre 3 integrated continuous glucose monitoring (iCGM) system.
Approximately 3 million FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors need to be replaced due to a risk of incorrect glucose readings. Abbott has received reports of 736 severe adverse events and seven deaths that may be related to this issue.
READ MORE >

Cardiology groups share new recommendations for performing safe, effective cardiac ablations in ASCs

The timing of this new guidance from the Heart Rhythm Society and American College of Cardiology could not have been better—the document went live just as CMS finalized its decision to cover cardiac ablation procedures performed in ASCs.

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heart doctor cardiologist
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Cardiology groups share new recommendations for performing safe, effective cardiac ablations in ASCs

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heart doctor cardiologist
The timing of this new guidance from the Heart Rhythm Society and American College of Cardiology could not have been better—the document went live just as CMS finalized its decision to cover cardiac ablation procedures performed in ASCs.
READ MORE >

Adjustable interatrial shunt for heart failure shows promise in first-in-human trial

Gregg Stone, MD, spoke to Cardiovascular Business about early data from the ATHENS-HF trial. Ten heart failure patients were treated with the adjustable device, and each implant was a success. 
 

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Gregg W. Stone, MD, Director of Academic Affairs for the Mount Sinai Health System and Professor of Medicine (Cardiology) and Professor of Population Health Science and Policy at the Icahn School of Medicine at Mount Sinai, discusses the ATHENS-HF Trial, a first-in-man study of a chronically-adjustbable, bi-atrial pressure sensing inter-atrial shunt from Adona Medical.
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Adjustable interatrial shunt for heart failure shows promise in first-in-human trial

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Gregg W. Stone, MD, Director of Academic Affairs for the Mount Sinai Health System and Professor of Medicine (Cardiology) and Professor of Population Health Science and Policy at the Icahn School of Medicine at Mount Sinai, discusses the ATHENS-HF Trial, a first-in-man study of a chronically-adjustbable, bi-atrial pressure sensing inter-atrial shunt from Adona Medical.
Gregg Stone, MD, spoke to Cardiovascular Business about early data from the ATHENS-HF trial. Ten heart failure patients were treated with the adjustable device, and each implant was a success.  
READ MORE >

IVC filter recalled due to injury risk

Customers are urged to stop using these devices right away.

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Argon Medical Devices Option Elite IVC filter
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IVC filter recalled due to injury risk

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Argon Medical Devices Option Elite IVC filter
Customers are urged to stop using these devices right away.
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In Case You Missed It

‘Unprecedented’: Single dose of new gene-editing therapy lowers cholesterol, triglycerides

First-in-human data suggest the therapy, CTX310, could be a breakthrough for patients with lipid disorders.

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A new gene-editing therapy has been tested on humans for the first time, resulting in a significant reduction in their low-density lipoprotein (LDL) cholesterol that could potentially last for decades. The study’s authors presented these early results at the AHA 2023 meeting.
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‘Unprecedented’: Single dose of new gene-editing therapy lowers cholesterol, triglycerides

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A new gene-editing therapy has been tested on humans for the first time, resulting in a significant reduction in their low-density lipoprotein (LDL) cholesterol that could potentially last for decades. The study’s authors presented these early results at the AHA 2023 meeting.
First-in-human data suggest the therapy, CTX310, could be a breakthrough for patients with lipid disorders.
READ MORE >

FDA clears new-look robotic system from Stereotaxis

GenesisX represents the company’s most accessible robotic system to date. It requires no room shielding or structural anchoring, for example, and the size has been significantly reduced.

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Stereotaxis GenesisX
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FDA clears new-look robotic system from Stereotaxis

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Stereotaxis GenesisX
GenesisX represents the company’s most accessible robotic system to date. It requires no room shielding or structural anchoring, for example, and the size has been significantly reduced.
READ MORE >

AI dramatically improves the detection of severe heart attacks

Researchers put an advanced AI model to the test, using it to evaluate the ECG results of more than 1,000 patients. It performed quite well. 

READ MORE >
artificial intelligence AI heart cardiology
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AI dramatically improves the detection of severe heart attacks

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artificial intelligence AI heart cardiology
Researchers put an advanced AI model to the test, using it to evaluate the ECG results of more than 1,000 patients. It performed quite well. 
READ MORE >

In Other News

Popular weight-loss drugs don’t tip the scales against Alzheimer’s

Semaglutide alters Alzheimer’s biomarkers but doesn’t slow the disease’s advance. 

READ MORE >
dementia patient
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Popular weight-loss drugs don’t tip the scales against Alzheimer’s

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dementia patient
Semaglutide alters Alzheimer’s biomarkers but doesn’t slow the disease’s advance. 
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Radiology societies urge caution when implementing AI in pediatric imaging

Six professional organizations including the Society for Pediatric Radiology made their case in a joint statement published across multiple medical journals Nov. 25. 

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U.S. News & World Report children’s hospitals cardiology heart surgery. SCAI said the Accelerating Kids' Access to Care Act would make it easier for children to access pediatric cardiology specialists in neighboring states when none are in their state, or out-of-state doctors are closer.
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Radiology societies urge caution when implementing AI in pediatric imaging

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U.S. News & World Report children’s hospitals cardiology heart surgery. SCAI said the Accelerating Kids' Access to Care Act would make it easier for children to access pediatric cardiology specialists in neighboring states when none are in their state, or out-of-state doctors are closer.
Six professional organizations including the Society for Pediatric Radiology made their case in a joint statement published across multiple medical journals Nov. 25. 
READ MORE >

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