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Week in Review: Tracking Class I recalls | AI IDs hypertension | FTC sues over insulin | LBBAP & TAVR

News You Need to Know Today
Week in Review: Tracking Class I recalls | AI IDs hypertension | FTC sues over insulin | LBBAP & TAVR
Saturday, September 28, 2024
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This Week’s News

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 >

AI detects hypertension in voice recordings

A machine learning-powered smartphone app was trained to detect hundreds of biomarkers in the human voice, using even the tiniest detail to anticipate when patients may present with symptoms of hypertension. 

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voice audio recording smartphone
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AI detects hypertension in voice recordings

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voice audio recording smartphone
A machine learning-powered smartphone app was trained to detect hundreds of biomarkers in the human voice, using even the tiniest detail to anticipate when patients may present with symptoms of hypertension. 
READ MORE >

Heart Failure Society of America cancels annual meeting in Atlanta due to Hurricane Helene

The news comes just one day before HFSA 2024 was scheduled to begin. HFSA is already considering the possibility of virtual sessions, but its primary concern is the safety of attendees. 

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Atlanta skyline
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Heart Failure Society of America cancels annual meeting in Atlanta due to Hurricane Helene

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Atlanta skyline
The news comes just one day before HFSA 2024 was scheduled to begin. HFSA is already considering the possibility of virtual sessions, but its primary concern is the safety of attendees. 
READ MORE >

Watchdog group, fearful of fraud, wants more oversight for remote patient monitoring

Cardiologists and other physicians may soon need to provide much more information when ordering remote patient monitoring for Medicare patients.

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insurance
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Watchdog group, fearful of fraud, wants more oversight for remote patient monitoring

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insurance
Cardiologists and other physicians may soon need to provide much more information when ordering remote patient monitoring for Medicare patients.
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Good documentation is the key to cardiac PET prior authorizations

Knowing what, exactly, is needed in cardiac PET documentation is one of the best ways to limit prior authorization issues.

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Erin R. Stevens, CNMT, NCT, director of nuclear medicine at Oregon Heart Center, said training physicians for what is needed in cardiac PET documentation is key for preventing issues with prior authorizations. ASNC photo
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Good documentation is the key to cardiac PET prior authorizations

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Erin R. Stevens, CNMT, NCT, director of nuclear medicine at Oregon Heart Center, said training physicians for what is needed in cardiac PET documentation is key for preventing issues with prior authorizations. ASNC photo
Knowing what, exactly, is needed in cardiac PET documentation is one of the best ways to limit prior authorization issues.
READ MORE >

FTC sues drug middlemen over insulin prices, puts others on notice

The FTC alleges that pharmacy benefit managers have set up a system where they get rich, while patients are forced to pay rising insulin costs. The agency also called out drug manufacturers such as Eli Lilly, Sanofi and Novo Nordisk, saying their own actions have raised serious concerns.

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A gavel and a stethoscope
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FTC sues drug middlemen over insulin prices, puts others on notice

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A gavel and a stethoscope
The FTC alleges that pharmacy benefit managers have set up a system where they get rich, while patients are forced to pay rising insulin costs. The agency also called out drug manufacturers such as Eli Lilly, Sanofi and Novo Nordisk, saying their own actions have raised serious concerns.
READ MORE >

Cardiologists say heart patients are often their own worst enemy

Patient lifestyles represent a significant challenge when treating and managing heart patients, according to a survey of more than 400 cardiologists. 

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The American College of Cardiology and American Heart Association have collaborated on a new update to the much-discussed 2021 chest pain guidelines. The American College of Emergency Physicians and Society for Cardiac Angiography and Interventions also contributed to the document.
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Cardiologists say heart patients are often their own worst enemy

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The American College of Cardiology and American Heart Association have collaborated on a new update to the much-discussed 2021 chest pain guidelines. The American College of Emergency Physicians and Society for Cardiac Angiography and Interventions also contributed to the document.
Patient lifestyles represent a significant challenge when treating and managing heart patients, according to a survey of more than 400 cardiologists. 
READ MORE >

LBBAP limits hospital readmissions after TAVR

Left bundle branch area pacing is associated with better long-term outcomes than traditional right ventricular pacing when patients require PPMI after TAVR, according to new research in Heart Rhythm. 

READ MORE >
cardiologist patient heart compensation starting salary 2022 interventional cardiologist
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LBBAP limits hospital readmissions after TAVR

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cardiologist patient heart compensation starting salary 2022 interventional cardiologist
Left bundle branch area pacing is associated with better long-term outcomes than traditional right ventricular pacing when patients require PPMI after TAVR, according to new research in Heart Rhythm. 
READ MORE >

ASE establishes vocabulary for cardiac POCUS to promote consistency

As cardiac point-of-care ultrasound use continues to grow outside of traditional echo labs, the American Society of Echocardiography is working to ensure everyone is on the same page.

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A cardiac point-of-care ultrasound (POCUS) exam being performed using a compact ultrasound system at the ASE annual meeting. Photo by Dave Fornell
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ASE establishes vocabulary for cardiac POCUS to promote consistency

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A cardiac point-of-care ultrasound (POCUS) exam being performed using a compact ultrasound system at the ASE annual meeting. Photo by Dave Fornell
As cardiac point-of-care ultrasound use continues to grow outside of traditional echo labs, the American Society of Echocardiography is working to ensure everyone is on the same page.
READ MORE >

Cardiology groups cheer new bill that would improve access to Medicare claims data

If passed, this bill would help clinician-led clinical registries explore Medicare data for research purposes. The Society of Thoracic Surgeons and American College of Cardiology both shared public support for the bipartisan legislation. 

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Medicare data stethoscope healthcare trends graphs finance financials
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Cardiology groups cheer new bill that would improve access to Medicare claims data

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Medicare data stethoscope healthcare trends graphs finance financials
If passed, this bill would help clinician-led clinical registries explore Medicare data for research purposes. The Society of Thoracic Surgeons and American College of Cardiology both shared public support for the bipartisan legislation. 
READ MORE >

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