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Week in Review: Catheters recalled | Cardiac ablations at ASCs | FDA clears new PFA system | Apple takes on hypertension

News You Need to Know Today
Week in Review: Catheters recalled | Cardiac ablations at ASCs | FDA clears new PFA system | Apple takes on hypertension
Saturday, September 13, 2025
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This Week’s News

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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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 >

Q&A: Cardiologist explores CMS proposal to cover cardiac ablations performed in ambulatory surgical centers

CMS has proposed a policy shift that would allow cardiac ablation procedures to be performed in ambulatory surgical centers. Arash Aryana, MD, PhD, a veteran cardiac electrophysiologist, explained why he is "extremely encouraged" by this proposal, highlighting several potential benefits. 

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Newsweek ranked the 50 best heart hospitals in the world
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Q&A: Cardiologist explores CMS proposal to cover cardiac ablations performed in ambulatory surgical centers

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Newsweek ranked the 50 best heart hospitals in the world
CMS has proposed a policy shift that would allow cardiac ablation procedures to be performed in ambulatory surgical centers. Arash Aryana, MD, PhD, a veteran cardiac electrophysiologist, explained why he is "extremely encouraged" by this proposal, highlighting several potential benefits. 
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.
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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 >

TAVR still a safe option for patients with nickel allergies

More research is still needed, as this study only included data from a small number of patients, but TAVR was not linked to any severe adverse events or allergic reactions.

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The Medtronic CoreValve Evolut and the Edwards Lifesciences Sapien 3 TAVR valves.
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TAVR still a safe option for patients with nickel allergies

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The Medtronic CoreValve Evolut and the Edwards Lifesciences Sapien 3 TAVR valves.
More research is still needed, as this study only included data from a small number of patients, but TAVR was not linked to any severe adverse events or allergic reactions.
READ MORE >

First study of its kind to focus on new therapy for hypoplastic left heart syndrome

The new trial represents a potential breakthrough in the treatment of one of the most devastating congenital heart defects.

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Joshua M. Hare, MD, FACC, FAHA, a professor of medicine, molecular and cellular pharmacology, and biomedical engineering, director of regenerative medicine, and director of the Interdisciplinary Stem Cell Institute (ISCI) at the University of Miami, and co-founder and chief science officer for the stem cell start-up Longeveron, explains the FDA trial for laromestrocel (Lomecel-B) to treat hypoplastic left heart syndrome (HLHS).
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First study of its kind to focus on new therapy for hypoplastic left heart syndrome

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Joshua M. Hare, MD, FACC, FAHA, a professor of medicine, molecular and cellular pharmacology, and biomedical engineering, director of regenerative medicine, and director of the Interdisciplinary Stem Cell Institute (ISCI) at the University of Miami, and co-founder and chief science officer for the stem cell start-up Longeveron, explains the FDA trial for laromestrocel (Lomecel-B) to treat hypoplastic left heart syndrome (HLHS).
The new trial represents a potential breakthrough in the treatment of one of the most devastating congenital heart defects.
READ MORE >

New Apple Watch Ultra 3 makes early hypertension detection a priority

"This tool empowers patients and clinicians to work together, putting prevention at the center of care," said Ami B. Bhatt, MD, ACC chief innovation officer. "What we really want to do is create patient agency and reach as many people as we can for earlier detection of high blood pressure."

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The new Apple Watch Ultra 3 offers a groundbreaking hypertension notifications alert users if signs of hypertension are detected using data from its optical heart sensor to analyze how a user’s blood vessels respond to heart beats. The algorithm works passively in the background, reviewing data over 30-day periods, and will notify users if it detects consistent signs of hypertension.
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New Apple Watch Ultra 3 makes early hypertension detection a priority

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The new Apple Watch Ultra 3 offers a groundbreaking hypertension notifications alert users if signs of hypertension are detected using data from its optical heart sensor to analyze how a user’s blood vessels respond to heart beats. The algorithm works passively in the background, reviewing data over 30-day periods, and will notify users if it detects consistent signs of hypertension.
"This tool empowers patients and clinicians to work together, putting prevention at the center of care," said Ami B. Bhatt, MD, ACC chief innovation officer. "What we really want to do is create patient agency and reach as many people as we can for earlier detection of high blood pressure."
READ MORE >

Plant-based diets linked to lower risks of death, heart disease, stroke and diabetes

Diets that prioritize plant-based foods are associated with several health benefits, according to a new study of more than 3.4 million adults. Such diets also show potential to reduce greenhouse gas emissions.

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Plant-based diets linked to lower risks of death, heart disease, stroke and diabetes

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diet nuts legumes vegetables vegan vegetarian plant-based
Diets that prioritize plant-based foods are associated with several health benefits, according to a new study of more than 3.4 million adults. Such diets also show potential to reduce greenhouse gas emissions.
READ MORE >

ASNC calls on members to fight 57% Medicare cut for cardiac amyloid imaging

Jamieson M. Bourque, MD, MHS, president-elect of the American Society of Nuclear Cardiology, shared the group's concerns with Cardiovascular Business. “This is going to have a highly negative impact," he said. 

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American Society of Nuclear Cardiology (ASNC) President-elect Jamieson M. Bourque, MD, MHS, FASNC, medical director of nuclear cardiology, echocardiography, and the stress laboratory at UVA Health in Charlottesville, and a professor of medicine and radiology at the University of Virginia, said the society is fighting a major proposed cut in CMS reimbursements in 2026.
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ASNC calls on members to fight 57% Medicare cut for cardiac amyloid imaging

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American Society of Nuclear Cardiology (ASNC) President-elect Jamieson M. Bourque, MD, MHS, FASNC, medical director of nuclear cardiology, echocardiography, and the stress laboratory at UVA Health in Charlottesville, and a professor of medicine and radiology at the University of Virginia, said the society is fighting a major proposed cut in CMS reimbursements in 2026.
Jamieson M. Bourque, MD, MHS, president-elect of the American Society of Nuclear Cardiology, shared the group's concerns with Cardiovascular Business. “This is going to have a highly negative impact," he said. 
READ MORE >

Key trends in nuclear cardiology take center stage at ASNC 2025

Wael Jaber, MD, chair of the 2025 American Society of Nuclear Cardiology annual meeting, shared some key takeaways from the conference. “This is no longer just about imaging for coronary disease," he explained. "Nuclear cardiology now helps guide therapy across a wide range of conditions."

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Video interview with Wael Jaber, MD, chair of the 2025 American Society of Nuclear Cardiology (ASNC) annual meeting, director of nuclear cardiology and a professor of medicine at Cleveland Clinic, shares some of the key highlights from the conference.
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Key trends in nuclear cardiology take center stage at ASNC 2025

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Video interview with Wael Jaber, MD, chair of the 2025 American Society of Nuclear Cardiology (ASNC) annual meeting, director of nuclear cardiology and a professor of medicine at Cleveland Clinic, shares some of the key highlights from the conference.
Wael Jaber, MD, chair of the 2025 American Society of Nuclear Cardiology annual meeting, shared some key takeaways from the conference. “This is no longer just about imaging for coronary disease," he explained. "Nuclear cardiology now helps guide therapy across a wide range of conditions."
READ MORE >

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