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News You Need to Know Today
New recalls for troubled heart devices | More procedures headed to ASCs | FDA clears next-gen mapping software | Heartflow's AI
Monday, December 15, 2025
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Today's News and Trends

New recalls announced for troubled heart devices—FDA previously urged customers to seek alternatives

These most recent recalls focus on a series of maintenance issues. In 2024, the FDA advised customers to transition away from the two devices and find alternative treatment options.

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Product Recall
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New recalls announced for troubled heart devices—FDA previously urged customers to seek alternatives

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Product Recall
These most recent recalls focus on a series of maintenance issues. In 2024, the FDA advised customers to transition away from the two devices and find alternative treatment options.
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 clears next-generation cardiac mapping software

San Diego-based Vektor Medical first secured FDA clearance for the AI-powered technology back in 2021. This updated announcement covers the latest version, which includes atrial flutter mapping and several other new features.

READ MORE >
heart data AI algorithm cardiologist doctor
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FDA clears next-generation cardiac mapping software

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heart data AI algorithm cardiologist doctor
San Diego-based Vektor Medical first secured FDA clearance for the AI-powered technology back in 2021. This updated announcement covers the latest version, which includes atrial flutter mapping and several other new features.
READ MORE >

AI-powered FFR-CT software linked to considerable cost savings, accurate predictions

According to Heartflow, its AI offering saves health systems nearly $1,400 per patient thanks to reductions in unnecessary cardiovascular testing.

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AI-powered FFR-CT software linked to considerable cost savings, accurate predictions

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According to Heartflow, its AI offering saves health systems nearly $1,400 per patient thanks to reductions in unnecessary cardiovascular testing.
READ MORE >

Featured Articles

Reimbursement expected to drive implementation of CCTA, coronary plaque analysis

For years, imaging experts have predicted that CCTA may become the primary imaging modality for coronary artery disease and eliminate the need for invasive diagnostic catheterizations. That prediction is now coming true.

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HeartFlow Plaque analysis AI software highlighting areas of interest in the coronaries with significant plaque burden and showing a cross sectional reformatted view with plaques. Demo at TCT 2024. DF
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Reimbursement expected to drive implementation of CCTA, coronary plaque analysis

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HeartFlow Plaque analysis AI software highlighting areas of interest in the coronaries with significant plaque burden and showing a cross sectional reformatted view with plaques. Demo at TCT 2024. DF
For years, imaging experts have predicted that CCTA may become the primary imaging modality for coronary artery disease and eliminate the need for invasive diagnostic catheterizations. That prediction is now coming true.
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 clears new stent-based coronary thrombectomy system

The newly cleared system offers clinicians a new option for capturing and removing large coronary thrombi in patients undergoing primary PCI.

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Vesalio enVast coronary mechanical thrombectomy system gained FDA in December 2025.
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FDA clears new stent-based coronary thrombectomy system

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Vesalio enVast coronary mechanical thrombectomy system gained FDA in December 2025.
The newly cleared system offers clinicians a new option for capturing and removing large coronary thrombi in patients undergoing primary PCI.
READ MORE >

The only heart failure treatment of its kind: Learn the latest billing recommendations for Barostim procedures

The Barostim device from CVRx continues to gain momentum as a go-to heart failure treatment. A free webinar is scheduled to examine the device's new CPT codes, which go into effect in 2026.

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Barostim Neo 2 CVRx heart failure nerve stimulator on display at HRS 2023. Photo by Dave Fornell
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The only heart failure treatment of its kind: Learn the latest billing recommendations for Barostim procedures

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Barostim Neo 2 CVRx heart failure nerve stimulator on display at HRS 2023. Photo by Dave Fornell
The Barostim device from CVRx continues to gain momentum as a go-to heart failure treatment. A free webinar is scheduled to examine the device's new CPT codes, which go into effect in 2026.
READ MORE >

In Case You Missed It

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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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 >

FDA clears TAVR guidewire built with BASILICA in mind

The Telltale system was designed to assist cardiologists when BASILICA is required prior to TAVR.

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approved approval
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FDA clears TAVR guidewire built with BASILICA in mind

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approved approval
The Telltale system was designed to assist cardiologists when BASILICA is required prior to TAVR.
READ MORE >

In Other News

Lawsuit claims clinic used AI to record patient conversations without consent

According to attorneys representing a potential class action of plaintiffs, Sharp HealthCare was not forthcoming about its use of a tool for automatic note-taking. The technology allegedly captures everything said in an exam room, including sensitive details on diagnoses, and sends it to an offsite server.

READ MORE >
voice audio recording smartphone
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Lawsuit claims clinic used AI to record patient conversations without consent

Share on Twitter Share on Facebook Share on Linkedin
voice audio recording smartphone
According to attorneys representing a potential class action of plaintiffs, Sharp HealthCare was not forthcoming about its use of a tool for automatic note-taking. The technology allegedly captures everything said in an exam room, including sensitive details on diagnoses, and sends it to an offsite server.
READ MORE >

News gems: Hospital price caps, costly drinking water, child-unready hospitals, more

A U.S. state is enjoying $50 million in annual savings after imposing price caps on its hospitals. OK—but what good things (or workers) got sacrificed?

READ MORE >
AI artificial intelligence in healthcare
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News gems: Hospital price caps, costly drinking water, child-unready hospitals, more

Share on Twitter Share on Facebook Share on Linkedin
AI artificial intelligence in healthcare
A U.S. state is enjoying $50 million in annual savings after imposing price caps on its hospitals. OK—but what good things (or workers) got sacrificed?
READ MORE >

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