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Patient files lawsuit over recall | Heart teams playing a major role | Abbott TAVR valve impresses | Preventing heart failure

News You Need to Know Today
Patient files lawsuit over recall | Heart teams playing a major role | Abbott TAVR valve impresses | Preventing heart failure
Monday, January 19, 2026
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Today's News and Trends

FDA confirms recalls for Abbott CGM sensors—new lawsuit alleges company concealed information

The FDA finalized four Class I recalls related to safety concerns first reported by Abbott in November. Meanwhile, a Florida man who uses these sensors to manage his diabetes has already filed a lawsuit over the issue.

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Abbott’s FreeStyle Libre 3 integrated continuous glucose monitoring (iCGM) system.
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FDA confirms recalls for Abbott CGM sensors—new lawsuit alleges company concealed information

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Abbott’s FreeStyle Libre 3 integrated continuous glucose monitoring (iCGM) system.
The FDA finalized four Class I recalls related to safety concerns first reported by Abbott in November. Meanwhile, a Florida man who uses these sensors to manage his diabetes has already filed a lawsuit over the issue.
READ MORE >

Heart teams playing a major role in coronary revascularization decisions

Sunil Rao, MD, discusses the heart team approach in the context of deciding what is best for the patient between bypass surgery and percutaneous coronary intervention.

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Sunil Rao, MD, director, interventional cardiology, cardiac catheterization laboratory, NYU Langone Heart, professor, Department of Medicine, the Leon H. Charney Division of Cardiology, NYU Grossman School of Medicine, discusses the heart team approach in the context to determining what is best for the patient in terms of bypass surgery or percutaneous coronary intervention.
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Heart teams playing a major role in coronary revascularization decisions

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Sunil Rao, MD, director, interventional cardiology, cardiac catheterization laboratory, NYU Langone Heart, professor, Department of Medicine, the Leon H. Charney Division of Cardiology, NYU Grossman School of Medicine, discusses the heart team approach in the context to determining what is best for the patient in terms of bypass surgery or percutaneous coronary intervention.
Sunil Rao, MD, discusses the heart team approach in the context of deciding what is best for the patient between bypass surgery and percutaneous coronary intervention.
READ MORE >

Abbott’s Navitor TAVR valve linked to positive real-world outcomes

The intra-annular, self-expanding Navitor valve gained FDA approval in 2023 for the treatment of high-risk heart patients with severe aortic stenosis. This analysis explores its early impact on patient care. 

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Navitor TAVR valve in the Abbott booth at TCT 2023. Photo by Dave Fornell
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Abbott’s Navitor TAVR valve linked to positive real-world outcomes

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Navitor TAVR valve in the Abbott booth at TCT 2023. Photo by Dave Fornell
The intra-annular, self-expanding Navitor valve gained FDA approval in 2023 for the treatment of high-risk heart patients with severe aortic stenosis. This analysis explores its early impact on patient care. 
READ MORE >

Heart failure experts share guidance on increasing prevention efforts

Cardiology has been shifting from reactionary treatment strategies to a greater emphasis on prevention. This is an especially important trend in heart failure, which is associated with high costs and rising hospitalization rates. 

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Cardiologist heart
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Heart failure experts share guidance on increasing prevention efforts

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Cardiologist heart
Cardiology has been shifting from reactionary treatment strategies to a greater emphasis on prevention. This is an especially important trend in heart failure, which is associated with high costs and rising hospitalization rates. 
READ MORE >

Featured Articles

Office-based interventional labs see boost in pay in 2026

CMS has made it a priority to increase payments for procedures performed by office-based labs and ambulatory surgical centers. This was reflected in policy changes made as part of the 2026 Medicare Physicians Fee Schedule.

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 Hospital patient bays recovery Banner Health and Atlas Ambulatory Surgical Center (ASC) in Sun City, Arizona.
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Office-based interventional labs see boost in pay in 2026

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 Hospital patient bays recovery Banner Health and Atlas Ambulatory Surgical Center (ASC) in Sun City, Arizona.
CMS has made it a priority to increase payments for procedures performed by office-based labs and ambulatory surgical centers. This was reflected in policy changes made as part of the 2026 Medicare Physicians Fee Schedule.
READ MORE >

Boston Scientific to acquire Penumbra for $14.5B

This is a cash and stock transaction that values Penumbra at $374 per share. The move helps Boston Scientific expand its vascular and neurovascular portfolios, gaining new treatments for pulmonary embolism, stroke, deep vein thrombosis and many other critical cardiovascular conditions. 

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business handshake
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Boston Scientific to acquire Penumbra for $14.5B

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business handshake
This is a cash and stock transaction that values Penumbra at $374 per share. The move helps Boston Scientific expand its vascular and neurovascular portfolios, gaining new treatments for pulmonary embolism, stroke, deep vein thrombosis and many other critical cardiovascular conditions. 
READ MORE >

TAVR’s next big challenge: Providing consistent relief for heart patients with aortic regurgitation

TAVR has already transformed care for patients with severe aortic stenosis. Will it make a similar impact on the treatment of aortic regurgitation?

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cardiologist patient heart compensation starting salary 2022 interventional cardiologist
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TAVR’s next big challenge: Providing consistent relief for heart patients with aortic regurgitation

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cardiologist patient heart compensation starting salary 2022 interventional cardiologist
TAVR has already transformed care for patients with severe aortic stenosis. Will it make a similar impact on the treatment of aortic regurgitation?
READ MORE >

FDA clears opportunistic AI for detecting cardiothoracic issues in CT scans

“Coronary calcium revealed long ago that atherosclerosis begins well before symptoms. AI-CVD extends that insight by enabling systematic identification of patients who are unaware of their cardiovascular risk using CT scans that already exist,” said Arthur Agatston, MD.

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The U.S. Food and Drug Administration (FDA) has cleared HeartLung Corporation's AI-CVD, an artificial intelligence (AI) algorithm that looks at 11 different opportunistic health screening assessments on chest CT exams ordered for any reason.
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FDA clears opportunistic AI for detecting cardiothoracic issues in CT scans

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The U.S. Food and Drug Administration (FDA) has cleared HeartLung Corporation's AI-CVD, an artificial intelligence (AI) algorithm that looks at 11 different opportunistic health screening assessments on chest CT exams ordered for any reason.
“Coronary calcium revealed long ago that atherosclerosis begins well before symptoms. AI-CVD extends that insight by enabling systematic identification of patients who are unaware of their cardiovascular risk using CT scans that already exist,” said Arthur Agatston, MD.
READ MORE >

In Case You Missed It

FDA approves new drug for genetic heart disease

Cytokinetics has secured FDA approval for aficamten, its new drug for the treatment of symptomatic obstructive HCM. Aficamten will be sold under the brand name Myqorzo. 

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Cytokinetics heart on gthe ACC24 show floor.
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FDA approves new drug for genetic heart disease

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Cytokinetics heart on gthe ACC24 show floor.
Cytokinetics has secured FDA approval for aficamten, its new drug for the treatment of symptomatic obstructive HCM. Aficamten will be sold under the brand name Myqorzo. 
READ MORE >

ACC calls for better management of peripheral artery disease in diabetic patients

PAD in patients with diabetes is common and associated with an increased risk of several adverse events. A new guidance from the American College of Cardiology reviewed this topic at length, identifying areas where care needs to improve.

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A diabetic foot ulcer that does not heal due to low blood supply from peripheral artery disease (PAD), and the before and after interventional angiograms of the patient's revascularization treatment. Images courtesy of Foluso Fakorede, MD
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ACC calls for better management of peripheral artery disease in diabetic patients

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A diabetic foot ulcer that does not heal due to low blood supply from peripheral artery disease (PAD), and the before and after interventional angiograms of the patient's revascularization treatment. Images courtesy of Foluso Fakorede, MD
PAD in patients with diabetes is common and associated with an increased risk of several adverse events. A new guidance from the American College of Cardiology reviewed this topic at length, identifying areas where care needs to improve.
READ MORE >

Abbott PFA system gains FDA approval

The Volt Pulsed Field Ablation System from Abbott has been approved by the FDA. The technology, which gained CE mark approval in March, features a one-of-a-kind catheter design and allows patients to be treated under conscious sedation.

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The Abbott Volt Pulsed Field Ablation catheter was cleared by the FDA in December 2025 and earlier had gained European CE mark.
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Abbott PFA system gains FDA approval

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The Abbott Volt Pulsed Field Ablation catheter was cleared by the FDA in December 2025 and earlier had gained European CE mark.
The Volt Pulsed Field Ablation System from Abbott has been approved by the FDA. The technology, which gained CE mark approval in March, features a one-of-a-kind catheter design and allows patients to be treated under conscious sedation.
READ MORE >

In Other News

Kaiser Permanente hit with record-setting $556M Medicare Advantage fraud settlement

The California-based health system faced multiple accusations of upcoding diagnoses to receive additional risk-adjusted payments from the Medicare Advantage program. Its payer plan and providers were implicated in what the DOJ described as systemic fraud. Kaiser Permanente denies any wrongdoing.

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the-kaiser-permanente-thrive-center-street-telegraph_1300x867.jpg
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Kaiser Permanente hit with record-setting $556M Medicare Advantage fraud settlement

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the-kaiser-permanente-thrive-center-street-telegraph_1300x867.jpg
The California-based health system faced multiple accusations of upcoding diagnoses to receive additional risk-adjusted payments from the Medicare Advantage program. Its payer plan and providers were implicated in what the DOJ described as systemic fraud. Kaiser Permanente denies any wrongdoing.
READ MORE >

Hospital leverages radiology waiting areas to boost cancer screening rates

Boston Medical Center has sought to have patients self-identify for lung cancer screening, administering multilingual surveys while they wait for imaging appointments. 

READ MORE >
waiting_room.jpg
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Hospital leverages radiology waiting areas to boost cancer screening rates

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waiting_room.jpg
Boston Medical Center has sought to have patients self-identify for lung cancer screening, administering multilingual surveys while they wait for imaging appointments. 
READ MORE >

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