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FDA confirms recall for heart device | Updates in AI reimbursement | Cardiologists urge Trump administration to kill proposal

News You Need to Know Today
FDA confirms recall for heart device | Updates in AI reimbursement | Cardiologists urge Trump administration to kill proposal
Saturday, December 27, 2025
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Editor's Choice: Policy & Regulations

FDA confirms new recall for Johnson & Johnson heart device over safety concerns

Three patient deaths have been linked to connectivity issues with these devices. The FDA has classified this as a Class I recall.

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FDA confirms new recall for Johnson & Johnson heart device over safety concerns

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FDA recall medical device recall product recall
Three patient deaths have been linked to connectivity issues with these devices. The FDA has classified this as a Class I recall.
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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 >

More interventional procedures may be coming to an ambulatory surgical center near you

ASCs have their limitations, but they are also associated with several benefits for cardiologists and patients alike.

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Arnold Seto, MD, MPA, FACC, FSCAI, cath lab director, Long Beach VA Medical Center, professor of medicine at Charles Drew University, Society for Cardiovascular Angiography and Interventions (SCAI) treasurer and chair of the SCAI Advocacy Committee, explains changes in payment policy are making ambulatory surgical centers (ASC) and office based labs (OBL) more attractive to both cardiologists and larger health systems.
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More interventional procedures may be coming to an ambulatory surgical center near you

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Arnold Seto, MD, MPA, FACC, FSCAI, cath lab director, Long Beach VA Medical Center, professor of medicine at Charles Drew University, Society for Cardiovascular Angiography and Interventions (SCAI) treasurer and chair of the SCAI Advocacy Committee, explains changes in payment policy are making ambulatory surgical centers (ASC) and office based labs (OBL) more attractive to both cardiologists and larger health systems.
ASCs have their limitations, but they are also associated with several benefits for cardiologists and patients alike.
READ MORE >

FDA panel votes against approving first-of-its-kind heart failure device

All 15 members of the FDA's Circulatory System Devices Panel agreed that more data is required to confirm the new device from Johnson & Johnson MedTech is effective. Will the agency agree with these recommendations? Only time will tell.

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V-Wave has gained considerable attention or its Ventura Interatrial Shunt System, a small implantable device designed to reduce pressure on the left atrium and the lungs in patients with heart failure with reduced ejection fraction (HFrEF). The Ventura device includes a nitinol hourglass-shaped frame that anchors to the patient’s fossa ovalis in a way that prevents migration or embolization. It is implanted via an interventional procedure with fluoroscopy and echocardiography guidance.
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FDA panel votes against approving first-of-its-kind heart failure device

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V-Wave has gained considerable attention or its Ventura Interatrial Shunt System, a small implantable device designed to reduce pressure on the left atrium and the lungs in patients with heart failure with reduced ejection fraction (HFrEF). The Ventura device includes a nitinol hourglass-shaped frame that anchors to the patient’s fossa ovalis in a way that prevents migration or embolization. It is implanted via an interventional procedure with fluoroscopy and echocardiography guidance.
All 15 members of the FDA's Circulatory System Devices Panel agreed that more data is required to confirm the new device from Johnson & Johnson MedTech is effective. Will the agency agree with these recommendations? Only time will tell.
READ MORE >

Cardiologists join chorus of voices urging Trump administration to kill cybersecurity proposal

The proposal, first announced by the Biden administration, was developed to improve patient data security. Those opposed argue that it would significantly increase costs and create a logistical nightmare for hospitals and health systems throughout the country.

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Cardiologists join chorus of voices urging Trump administration to kill cybersecurity proposal

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Cybersecurity lock
The proposal, first announced by the Biden administration, was developed to improve patient data security. Those opposed argue that it would significantly increase costs and create a logistical nightmare for hospitals and health systems throughout the country.
READ MORE >

CMS considers Medicare coverage for TAVR in asymptomatic patients

After an official request from Edwards Lifesciences, CMS is rethinking its coverage policy for the use of TAVR to treat asymptomatic severe aortic stenosis. The agency is accepting public comments on this topic until Jan. 14. 

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Illustration of cardiologists going through the certification process. American College of Cardiology President B. Hadley Wilson, MD, discussed why the ACC and other leading cardiology groups are so eager to create a new, independent medical board. This has been a long-term goal for many years, he said, and now it may become a reality. 
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CMS considers Medicare coverage for TAVR in asymptomatic patients

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Illustration of cardiologists going through the certification process. American College of Cardiology President B. Hadley Wilson, MD, discussed why the ACC and other leading cardiology groups are so eager to create a new, independent medical board. This has been a long-term goal for many years, he said, and now it may become a reality. 
After an official request from Edwards Lifesciences, CMS is rethinking its coverage policy for the use of TAVR to treat asymptomatic severe aortic stenosis. The agency is accepting public comments on this topic until Jan. 14. 
READ MORE >

Bleeding reversal agent pulled from market over FDA’s safety concerns

AstraZeneca has stopped selling Andexxa because randomized data suggested some patients may face an increased risk of certain adverse events. The company emphasized that it remains confident in the agent's abilities.

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warning safety alert recall healthcare issue
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Bleeding reversal agent pulled from market over FDA’s safety concerns

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warning safety alert recall healthcare issue
AstraZeneca has stopped selling Andexxa because randomized data suggested some patients may face an increased risk of certain adverse events. The company emphasized that it remains confident in the agent's abilities.
READ MORE >

Cardiology’s biggest trend: New scientific statements take on AI-powered coronary plaque evaluations

The ACC and AHA both issued new statements on noninvasive CCTA offerings that use advanced AI to evaluate patients with suspected CAD. These technologies have gained significant momentum in recent years, and experts agree that they represent a game-changing advancement in the world of cardiovascular imaging.

READ MORE >
HeartFlow Plaque Analysis. A European Heart Journal – Cardiovascular Imaging study compared the noninvasive Plaque Analysis technology developed by HeartFlow, which uses advanced AI algorithms to evaluate coronary CT angiography (CCTA) images, with coronary plaque assessments achieved by using intravascular ultrasound (IVUS). The REVEALPLAQUE trial included data from 237 patients. Plaque Analysis showed strong correlation and high accuracy when compared with IVUS.
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Cardiology’s biggest trend: New scientific statements take on AI-powered coronary plaque evaluations

Share on Twitter Share on Facebook Share on Linkedin
HeartFlow Plaque Analysis. A European Heart Journal – Cardiovascular Imaging study compared the noninvasive Plaque Analysis technology developed by HeartFlow, which uses advanced AI algorithms to evaluate coronary CT angiography (CCTA) images, with coronary plaque assessments achieved by using intravascular ultrasound (IVUS). The REVEALPLAQUE trial included data from 237 patients. Plaque Analysis showed strong correlation and high accuracy when compared with IVUS.
The ACC and AHA both issued new statements on noninvasive CCTA offerings that use advanced AI to evaluate patients with suspected CAD. These technologies have gained significant momentum in recent years, and experts agree that they represent a game-changing advancement in the world of cardiovascular imaging.
READ MORE >

Cardiologist reportedly fired over role with CDC vaccine panel—wife calls it a ‘staggering turn of events’

Kirk Milhoan, MD, PhD, has been fired from his role as a pediatric cardiologist. His wife and others say he was let go because he is now the chair of the CDC’s Advisory Committee on Immunization Practices.

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Kirk Milhoan, MD, PhD, a veteran physician who was recently named the chair of the CDC’s Advisory Committee on Immunization Practices (ACIP), has reportedly been fired from his day-to-day role as a pediatric cardiologist.
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Cardiologist reportedly fired over role with CDC vaccine panel—wife calls it a ‘staggering turn of events’

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Kirk Milhoan, MD, PhD, a veteran physician who was recently named the chair of the CDC’s Advisory Committee on Immunization Practices (ACIP), has reportedly been fired from his day-to-day role as a pediatric cardiologist.
Kirk Milhoan, MD, PhD, has been fired from his role as a pediatric cardiologist. His wife and others say he was let go because he is now the chair of the CDC’s Advisory Committee on Immunization Practices.
READ MORE >

FDA approves new nasal spray for patients with abnormal heart rhythms

Milestone Pharmaceuticals will be selling etripamil under the brand name Cardamyst. It is expected to hit the U.S. market in early 2026.

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Milestone Pharmaceuticals has received U.S. Food and Drug Administration (FDA) approval for etripamil, a new nasal spray for adult patients with paroxysmal supraventricular tachycardia (PSVT).
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FDA approves new nasal spray for patients with abnormal heart rhythms

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Milestone Pharmaceuticals has received U.S. Food and Drug Administration (FDA) approval for etripamil, a new nasal spray for adult patients with paroxysmal supraventricular tachycardia (PSVT).
Milestone Pharmaceuticals will be selling etripamil under the brand name Cardamyst. It is expected to hit the U.S. market in early 2026.
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.

READ MORE >
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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 >

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