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News You Need to Know Today
September's Top Stories: A historic procedure | Private practice sues hospital | FDA approves radiotracer | TAVR bests SAVR
Wednesday, October 2, 2024
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The Month in Review

Surgeons make history, perform world’s first fully robotic heart transplant

The procedure, which lasted roughly two and half hours, was performed on a 16-year-old patient with end-stage heart failure. 

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A heart team at King Faisal Specialist Hospital & Research Center (KFSHRC) in Riyadh, Saudi Arabia, made a bit of history, completing the world’s first fully robotic heart transplant. The procedure, which lasted roughly two and half hours, was performed on a 16-year-old patient with end-stage heart failure. One reason this patient was selected was the fact that he had specifically requested the heart team not open his chest.
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Surgeons make history, perform world’s first fully robotic heart transplant

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A heart team at King Faisal Specialist Hospital & Research Center (KFSHRC) in Riyadh, Saudi Arabia, made a bit of history, completing the world’s first fully robotic heart transplant. The procedure, which lasted roughly two and half hours, was performed on a 16-year-old patient with end-stage heart failure. One reason this patient was selected was the fact that he had specifically requested the heart team not open his chest.
The procedure, which lasted roughly two and half hours, was performed on a 16-year-old patient with end-stage heart failure. 
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Most recalled cardiovascular devices gained FDA approval with little to no clinical evidence

Why are so many cardiovascular devices involved in Class I recalls? One possible reason could be the large number of devices hitting the market without undergoing much premarket clinical testing. 

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A majority of medical devices involved in Class I recalls were never required by the U.S. Food and Drug Administration (FDA) to undergo premarket or postmarket clinical testing, according to new research published in Annals of Internal Medicine.[1]
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Most recalled cardiovascular devices gained FDA approval with little to no clinical evidence

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A majority of medical devices involved in Class I recalls were never required by the U.S. Food and Drug Administration (FDA) to undergo premarket or postmarket clinical testing, according to new research published in Annals of Internal Medicine.[1]
Why are so many cardiovascular devices involved in Class I recalls? One possible reason could be the large number of devices hitting the market without undergoing much premarket clinical testing. 
READ MORE >

Private cardiology practice accuses hospital of intimidation, defamation in $15M lawsuit

According to Oregon Heart Center, an independent cardiology practice, Salem Health is attempting to "monopolize cardiology care" in the area. The two providers had previously coexisted for years. 

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Former managers of a Tampa Florida-based radiology company Advanced Diagnostic Group (ADG) and its employee stock ownership plan (ESOP) retirement benefit manager GreatBanc Trust Co. will pay $19 million to settle a class action lawsuit. The suit alleges they allowed the ESOP’s value to be diverted to managers, directors and their shell companies and away from employee participants. money gavel court lawsuit legal judge judgement
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Private cardiology practice accuses hospital of intimidation, defamation in $15M lawsuit

Share on Twitter Share on Facebook Share on Linkedin
Former managers of a Tampa Florida-based radiology company Advanced Diagnostic Group (ADG) and its employee stock ownership plan (ESOP) retirement benefit manager GreatBanc Trust Co. will pay $19 million to settle a class action lawsuit. The suit alleges they allowed the ESOP’s value to be diverted to managers, directors and their shell companies and away from employee participants. money gavel court lawsuit legal judge judgement
According to Oregon Heart Center, an independent cardiology practice, Salem Health is attempting to "monopolize cardiology care" in the area. The two providers had previously coexisted for years. 
READ MORE >

Viz.ai partners with Cleerly in the name of AI-based CCTA evaluations

The new partnership is focused on getting advanced AI algorithms into the hands of cardiologists.

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robot reviewing heart data
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Viz.ai partners with Cleerly in the name of AI-based CCTA evaluations

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robot reviewing heart data
The new partnership is focused on getting advanced AI algorithms into the hands of cardiologists.
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Cardiologist dies after tragic accident—remembered as a ‘truly remarkable physician’

The 59-year-old cardiologist was known for both his clinical knowledge and his warm personality. He practiced with the same city hospital for nearly three decades. 

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candles funeral dead respect
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Cardiologist dies after tragic accident—remembered as a ‘truly remarkable physician’

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candles funeral dead respect
The 59-year-old cardiologist was known for both his clinical knowledge and his warm personality. He practiced with the same city hospital for nearly three decades. 
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Cardiac PET on the rise among U.S. cardiologists

SPECT is still the most common modality used to evaluate CAD patients, but cardiac PET is gaining more and more momentum.

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For almost nine years since the adoption of the Protecting Access to Medicare Act (PAMA) established the requirement for appropriate use criteria (AUC) to receive payment for advanced diagnostic imaging, the American Society of Nuclear Cardiology (ASNC) has lobbying Congressional leaders change or repeal AUC mandate. Those efforts have paid off in the 2024 Medicare Physician Fee Schedule final rule, where AUC program has been paused and all of its regulations were rescinded. Photo by Dave Fornell.
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Cardiac PET on the rise among U.S. cardiologists

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For almost nine years since the adoption of the Protecting Access to Medicare Act (PAMA) established the requirement for appropriate use criteria (AUC) to receive payment for advanced diagnostic imaging, the American Society of Nuclear Cardiology (ASNC) has lobbying Congressional leaders change or repeal AUC mandate. Those efforts have paid off in the 2024 Medicare Physician Fee Schedule final rule, where AUC program has been paused and all of its regulations were rescinded. Photo by Dave Fornell.
SPECT is still the most common modality used to evaluate CAD patients, but cardiac PET is gaining more and more momentum.
READ MORE >

Safety update: Sensor issue with Abbott CGMs ruled a Class I recall

The sensors of certain FreeStyle Libre 3 devices are producing inaccurate glucose readings and should not be used. Two patient injuries have been reported. Abbott first reported the problem in July. 

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Abbott’s FreeStyle Libre 3 integrated continuous glucose monitoring (iCGM) system.
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Safety update: Sensor issue with Abbott CGMs ruled a Class I recall

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Abbott’s FreeStyle Libre 3 integrated continuous glucose monitoring (iCGM) system.
The sensors of certain FreeStyle Libre 3 devices are producing inaccurate glucose readings and should not be used. Two patient injuries have been reported. Abbott first reported the problem in July. 
READ MORE >

FDA approves GE HealthCare's flurpiridaz F-18 PET radiotracer for CAD

The newly approved radiotracer is seen as a major step forward for nuclear imaging technology. Specialists have been looking forward to its arrival on the market for quite some time.

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The new cardiac PET radiotracer flurpiridaz F-18 is posed to be a major game changer and will likely lead to increased adoption of cardiac PET.
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FDA approves GE HealthCare's flurpiridaz F-18 PET radiotracer for CAD

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The new cardiac PET radiotracer flurpiridaz F-18 is posed to be a major game changer and will likely lead to increased adoption of cardiac PET.
The newly approved radiotracer is seen as a major step forward for nuclear imaging technology. Specialists have been looking forward to its arrival on the market for quite some time.
READ MORE >

FDA clears AI platform for planning ahead of TAVR, other heart procedures

The cloud-based platform identifies and measures cardiac structures in CT scans.

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The rapid rise of artificial intelligence (AI) has helped cardiologists, radiologists, nurses and other healthcare providers embrace precision medicine in a way that ensures more heart patients are receiving personalized care.
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FDA clears AI platform for planning ahead of TAVR, other heart procedures

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The rapid rise of artificial intelligence (AI) has helped cardiologists, radiologists, nurses and other healthcare providers embrace precision medicine in a way that ensures more heart patients are receiving personalized care.
The cloud-based platform identifies and measures cardiac structures in CT scans.
READ MORE >

TAVR outperforms SAVR when treating women, historic all-female trial confirms

The study, presented at ESC Congress 2024 in London, confirmed that TAVR was associated with significantly better outcomes than surgery when treating female patients. 

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The SAPIEN 3 Ultra (S3U) transcatheter heart valve from Edwards Lifesciences. A study presented at ESC Congress 2024 in London, confirmed that TAVR was associated with significantly better outcomes than surgery when treating female patients.
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TAVR outperforms SAVR when treating women, historic all-female trial confirms

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The SAPIEN 3 Ultra (S3U) transcatheter heart valve from Edwards Lifesciences. A study presented at ESC Congress 2024 in London, confirmed that TAVR was associated with significantly better outcomes than surgery when treating female patients.
The study, presented at ESC Congress 2024 in London, confirmed that TAVR was associated with significantly better outcomes than surgery when treating female patients. 
READ MORE >

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