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Historic pacemaker implants | IVL tech a top priority | CEO resigns over conduct allegations | FDA clears new heart monitor

News You Need to Know Today
Historic pacemaker implants | IVL tech a top priority | CEO resigns over conduct allegations | FDA clears new heart monitor
Wednesday, December 18, 2024
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Today's News and Trends

Cardiologists perform world’s first leadless LBBAP procedures with Abbott pacemaker

The first-in-human procedures were performed in Prague with the investigational Aveir CSP leadless pacemaker system.

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Left: Petr Neužil, MD, PhD, head of the department of cardiology at Na Homolce Hospital in Prague, Czech Republic / Right: Vivek Y. Reddy, MD, director of cardiac arrhythmia services at Mount Sinai Hospital in New York City
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Cardiologists perform world’s first leadless LBBAP procedures with Abbott pacemaker

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Left: Petr Neužil, MD, PhD, head of the department of cardiology at Na Homolce Hospital in Prague, Czech Republic / Right: Vivek Y. Reddy, MD, director of cardiac arrhythmia services at Mount Sinai Hospital in New York City
The first-in-human procedures were performed in Prague with the investigational Aveir CSP leadless pacemaker system.
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Intravascular lithotripsy technology now a top priority for many healthcare companies

After the significant success of Shockwave Medical's IVL therapy to break up heavily calcified vessels without trauma, there are now several companies working on their own IVL devices. 

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Philips Healthcare's combined IVL and laser atherectomy catheter that is being used in the THOR trial to treat heavily calcified peripheral artery lesions.
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Intravascular lithotripsy technology now a top priority for many healthcare companies

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Philips Healthcare's combined IVL and laser atherectomy catheter that is being used in the THOR trial to treat heavily calcified peripheral artery lesions.
After the significant success of Shockwave Medical's IVL therapy to break up heavily calcified vessels without trauma, there are now several companies working on their own IVL devices. 
READ MORE >

President of medical device company resigns over conduct allegations after 7 months in role

Joseph C. Wright, a longtime Merit Medical employee, resigned after unspecified allegations regarding his conduct were brought to light. He was named the company's new president back in May.

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Joseph C. Wright resigns from Merit Medical
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President of medical device company resigns over conduct allegations after 7 months in role

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Joseph C. Wright resigns from Merit Medical
Joseph C. Wright, a longtime Merit Medical employee, resigned after unspecified allegations regarding his conduct were brought to light. He was named the company's new president back in May.
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FDA clears credit card-sized heart monitor

The new device was designed to help patients evaluate their own heart health in real time.

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HeartBeam, a California-based healthcare technology company, has received U.S. Food and Drug Administration (FDA) clearance for its cable-free, credit card-sized heart monitor that produces 12-lead electrocardiograms (ECGs).
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FDA clears credit card-sized heart monitor

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HeartBeam, a California-based healthcare technology company, has received U.S. Food and Drug Administration (FDA) clearance for its cable-free, credit card-sized heart monitor that produces 12-lead electrocardiograms (ECGs).
The new device was designed to help patients evaluate their own heart health in real time.
READ MORE >

Featured Articles

FDA and Boston Scientific issue urgent alert about pacemaker failures following 2 deaths

The U.S. Food and Drug Administration issued the recall notice for more than 200,000 pacemakers because a battery issue could lock the device in safe mode. 

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Boston Scientific recalls more than 200,000 pacemakers after 2 deaths and 697 confirmed malfunctions.
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FDA and Boston Scientific issue urgent alert about pacemaker failures following 2 deaths

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Boston Scientific recalls more than 200,000 pacemakers after 2 deaths and 697 confirmed malfunctions.
The U.S. Food and Drug Administration issued the recall notice for more than 200,000 pacemakers because a battery issue could lock the device in safe mode. 
READ MORE >

SCAI president reviews achievements in interventional cardiology in 2024

SCAI President James Hermiller, MD, recently outlined the key achievements for 2024, including creation of the first interventional cardiology match program, successful advocacy and efforts to increase women in the field.

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Society Society for Cardiovascular Angiography and Interventions (SCAI) President James Hermiller, MD, discusses achievements of SCAI in 2024. #SCAI
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SCAI president reviews achievements in interventional cardiology in 2024

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Society Society for Cardiovascular Angiography and Interventions (SCAI) President James Hermiller, MD, discusses achievements of SCAI in 2024. #SCAI
SCAI President James Hermiller, MD, recently outlined the key achievements for 2024, including creation of the first interventional cardiology match program, successful advocacy and efforts to increase women in the field.
READ MORE >

In Case You Missed It

More vulnerable, but still treatable: Frail heart patients benefit from PCI, CABG

High-risk patients are often treated with medical therapy alone instead of revascularization. However, new data make it clear that these patients can live much longer when treated with PCI or CABG.

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With advances and increased experience in the percutaneous coronary intervention (PCI), same-day discharge (SDD) has become increasingly commonplace, but patient selection is key. Antithrombotic therapy may not be necessary for certain transcatheter aortic valve replacement (TAVR) patients, according to a new analysis published in JACC: Cardiovascular Interventions.
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More vulnerable, but still treatable: Frail heart patients benefit from PCI, CABG

Share on Twitter Share on Facebook Share on Linkedin
With advances and increased experience in the percutaneous coronary intervention (PCI), same-day discharge (SDD) has become increasingly commonplace, but patient selection is key. Antithrombotic therapy may not be necessary for certain transcatheter aortic valve replacement (TAVR) patients, according to a new analysis published in JACC: Cardiovascular Interventions.
High-risk patients are often treated with medical therapy alone instead of revascularization. However, new data make it clear that these patients can live much longer when treated with PCI or CABG.
READ MORE >

Medical device company cuts 70% of staff in push to meet Medtronic obligations

California-based Acutus Medical has said its ongoing agreement to manufacture and distribute left-heart access devices for Medtronic is the company's only source of revenue. 

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Acutus Medical, the California-based healthcare technology company focused on electrophysiology devices, has announced significant downsizing that will cut its workforce by approximately 70%. The goal of the move is to focus exclusively on manufacturing and distributing left-heart access devices as part of a distribution deal with Medtronic that was first signed in 2022.
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Medical device company cuts 70% of staff in push to meet Medtronic obligations

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Acutus Medical, the California-based healthcare technology company focused on electrophysiology devices, has announced significant downsizing that will cut its workforce by approximately 70%. The goal of the move is to focus exclusively on manufacturing and distributing left-heart access devices as part of a distribution deal with Medtronic that was first signed in 2022.
California-based Acutus Medical has said its ongoing agreement to manufacture and distribute left-heart access devices for Medtronic is the company's only source of revenue. 
READ MORE >

Interventional cardiology’s first Match Day celebrated as a ‘historic achievement’

This was a moment years in the making for interventional cardiology. A total of 164 training programs participated, and 94% of applicants secured a position. 

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partnership business deal joint venture
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Interventional cardiology’s first Match Day celebrated as a ‘historic achievement’

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partnership business deal joint venture
This was a moment years in the making for interventional cardiology. A total of 164 training programs participated, and 94% of applicants secured a position. 
READ MORE >

In Other News

Healthcare AI regulation needs nuance, balance: Research review

When regulating AI-equipped medical devices, the FDA might take a page from the Department of Transportation’s playbook for overseeing AI-equipped vehicles. These run the gamut from assisting human drivers to fully taking the wheel. 

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artificial intelligence AI healthcare regulation FDA
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Healthcare AI regulation needs nuance, balance: Research review

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artificial intelligence AI healthcare regulation FDA
When regulating AI-equipped medical devices, the FDA might take a page from the Department of Transportation’s playbook for overseeing AI-equipped vehicles. These run the gamut from assisting human drivers to fully taking the wheel. 
READ MORE >

Radiology CEO discusses bankruptcy and why he’s optimistic about his company’s second-chance future

Radiology Business sat down with Akumin's new CEO, Krishna Kumar, MBA, who took over the role in February, the same month the organization emerged from Chapter 11. 

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Krishna Kumar Akumin Philips
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Radiology CEO discusses bankruptcy and why he’s optimistic about his company’s second-chance future

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Krishna Kumar Akumin Philips
Radiology Business sat down with Akumin's new CEO, Krishna Kumar, MBA, who took over the role in February, the same month the organization emerged from Chapter 11. 
READ MORE >

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