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News You Need to Know Today
FDA's Impella warning | Improving care worldwide | AI evaluates risk | Battle of the ATTR-CM drugs | Medtech veteran's new gig
Thursday, September 24, 2026
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Today's News and Trends

FDA warns that certain Impella heart pump controllers may need serviced

This latest alert comes after Johnson & Johnson MedTech found that certain devices may require hardware, firmware and/or software updates to address safety concerns. 

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The FDA has identified another safety concern with Johnson & Johnson MedTech's Automated Impella Controllers. This comes after the devices were linked to five separate recalls in 2025.
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FDA warns that certain Impella heart pump controllers may need serviced

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The FDA has identified another safety concern with Johnson & Johnson MedTech's Automated Impella Controllers. This comes after the devices were linked to five separate recalls in 2025.
This latest alert comes after Johnson & Johnson MedTech found that certain devices may require hardware, firmware and/or software updates to address safety concerns. 
READ MORE >

American Heart Association helping countries all over the world improve care

The AHA has developed systems of care that can help developing countries improve their treatment strategies for both heart attack and stroke.

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Damodhar Suresh, MD, executive medical director of St. Elizabeth Healthcare Heart and Vascular Institute in Edgewood, Kentucky. He is also a volunteer current science chair for the International committee for the American Heart Association (AHA), explains how the AHA is helping cardiologists from numerous countries put in place systems of care to standardize how heart attack patients are treated.
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American Heart Association helping countries all over the world improve care

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Damodhar Suresh, MD, executive medical director of St. Elizabeth Healthcare Heart and Vascular Institute in Edgewood, Kentucky. He is also a volunteer current science chair for the International committee for the American Heart Association (AHA), explains how the AHA is helping cardiologists from numerous countries put in place systems of care to standardize how heart attack patients are treated.
The AHA has developed systems of care that can help developing countries improve their treatment strategies for both heart attack and stroke.
READ MORE >

AI uses routine CT images to evaluate cardiovascular risk

Researchers have trained a new AI model to read routine medical images and deliver accurate cardiovascular age assessments.

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artificial intelligence AI heart cardiology
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AI uses routine CT images to evaluate cardiovascular risk

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artificial intelligence AI heart cardiology
Researchers have trained a new AI model to read routine medical images and deliver accurate cardiovascular age assessments.
READ MORE >

Acoramidis bests tafamidis in head-to-head comparison of ATTR-CM drugs

Acoramidis was associated with a 43% lower risk of diuretic intensification and a 34% lower risk of clinical worsening overall.

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Cardiac amyloidosis ATTR-CM drug promotion at the 2024 American Heart Association meeting.
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Acoramidis bests tafamidis in head-to-head comparison of ATTR-CM drugs

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Cardiac amyloidosis ATTR-CM drug promotion at the 2024 American Heart Association meeting.
Acoramidis was associated with a 43% lower risk of diuretic intensification and a 34% lower risk of clinical worsening overall.
READ MORE >

CVRx names medtech veteran its new CFO

John Landry joins Minneapolis-based CVRx with more than 20 years of experience as a financial leader in the medtech space. 

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John Landry, CFO of CVRx
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CVRx names medtech veteran its new CFO

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John Landry, CFO of CVRx
John Landry joins Minneapolis-based CVRx with more than 20 years of experience as a financial leader in the medtech space. 
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Featured Articles

Cardiologist impaled by tree branch makes a full recovery

The doctor, visiting Montana from Pennsylvania for a ski trip, says he did not even realize at first what had happened.

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Skiing
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Cardiologist impaled by tree branch makes a full recovery

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Skiing
The doctor, visiting Montana from Pennsylvania for a ski trip, says he did not even realize at first what had happened.
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First heart procedure of its kind performed in US after careful planning

Specialists from the fields of interventional cardiology and cardiac surgery collaborated to perform what is believed to be the first completely catheter-based Fontan procedure in U.S. history. The young patient's recovery was much easier than it would have been otherwise. 

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The Nicklaus Children’s Hospital Heart Institute was the first to perform a completely catheter-based Fontan procedure. Rather than using open-heart surgery to complete the child’s Fontan circulation, the 2-year-old born with a double-outlet right ventricle underwent a catheter-based approach to avoid open-heart surgery.
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First heart procedure of its kind performed in US after careful planning

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The Nicklaus Children’s Hospital Heart Institute was the first to perform a completely catheter-based Fontan procedure. Rather than using open-heart surgery to complete the child’s Fontan circulation, the 2-year-old born with a double-outlet right ventricle underwent a catheter-based approach to avoid open-heart surgery.
Specialists from the fields of interventional cardiology and cardiac surgery collaborated to perform what is believed to be the first completely catheter-based Fontan procedure in U.S. history. The young patient's recovery was much easier than it would have been otherwise. 
READ MORE >

TAVR timing: Waiting more than 6 months may hurt survival odds

When heart patients are diagnosed with severe AS, how quickly do they need to undergo TAVR? That was the focus of a new analysis published in Open Heart.

READ MORE >
wait times waiting hour glass calendar delay
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TAVR timing: Waiting more than 6 months may hurt survival odds

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wait times waiting hour glass calendar delay
When heart patients are diagnosed with severe AS, how quickly do they need to undergo TAVR? That was the focus of a new analysis published in Open Heart.
READ MORE >

FDA clears new heart preservation system for transplants

The news comes as clinical evidence supporting heart preservation at 50 degrees F (10 degrees C) continues to grow.

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The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for Traferox Technologies' X°Port Heart Preservation System. The new device offers static 10°C (50°F) heart preservation during transport prior to transplantation, which has been shown in studies to improve outcomes.
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FDA clears new heart preservation system for transplants

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The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for Traferox Technologies' X°Port Heart Preservation System. The new device offers static 10°C (50°F) heart preservation during transport prior to transplantation, which has been shown in studies to improve outcomes.
The news comes as clinical evidence supporting heart preservation at 50 degrees F (10 degrees C) continues to grow.
READ MORE >

In Case You Missed It

Tricuspid valve repair linked to major benefits for high-risk heart patients

While T-TEER is already known to improve a patient's quality of life, this late-breaking study from ESC Congress 2026 confirmed it also improves survival and reduces the risk of heart failure hospitalization.

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An FDA panel will discuss its recommendations related to Abbott's TriClip G4 transcatheter edge-to-edge repair (TEER) system for tricuspid regurgitation.
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Tricuspid valve repair linked to major benefits for high-risk heart patients

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An FDA panel will discuss its recommendations related to Abbott's TriClip G4 transcatheter edge-to-edge repair (TEER) system for tricuspid regurgitation.
While T-TEER is already known to improve a patient's quality of life, this late-breaking study from ESC Congress 2026 confirmed it also improves survival and reduces the risk of heart failure hospitalization.
READ MORE >

Medtronic invests up to $80M in medtech company Pi-Cardia with a potential buyout on the table

Less than a year after investing heavily in Minnesota-based Anteris Technologies, Medtronic has announced a new strategic investment in Pi-Cardia. The TAVR technology at the heart of this investment is Pi-Cardia's FDA-approved ShortCut device. 

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Pi-Cardia ShortCut TAVR device. According to Pi-Cardia, ShortCut is the first medical device of its kind; interventional cardiologists use it to split valve leaflets in patients who have been recommended for valve-in-valve TAVR and face a heightened coronary obstruction risk.
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Medtronic invests up to $80M in medtech company Pi-Cardia with a potential buyout on the table

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Pi-Cardia ShortCut TAVR device. According to Pi-Cardia, ShortCut is the first medical device of its kind; interventional cardiologists use it to split valve leaflets in patients who have been recommended for valve-in-valve TAVR and face a heightened coronary obstruction risk.
Less than a year after investing heavily in Minnesota-based Anteris Technologies, Medtronic has announced a new strategic investment in Pi-Cardia. The TAVR technology at the heart of this investment is Pi-Cardia's FDA-approved ShortCut device. 
READ MORE >

Even cardiologists and other clinicians struggle to manage their own cardiovascular health

Clinicians who dedicate their lives to helping others may not always take care of their own health, according to new data presented at ESC Congress 2026.

READ MORE >
Group of doctors.jpg
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Even cardiologists and other clinicians struggle to manage their own cardiovascular health

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Group of doctors.jpg
Clinicians who dedicate their lives to helping others may not always take care of their own health, according to new data presented at ESC Congress 2026.
READ MORE >

In Other News

CMS kicks 760,000 people off ACA plans in crackdown on ‘unauthorized’ broker-supported enrollments

The Centers for Medicare & Medicaid Services said agents and brokers, acting on behalf of enrollees, were failing to submit necessary documentation on applications, such as Social Security numbers and immigration details. 

READ MORE >
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CMS kicks 760,000 people off ACA plans in crackdown on ‘unauthorized’ broker-supported enrollments

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The Centers for Medicare & Medicaid Services said agents and brokers, acting on behalf of enrollees, were failing to submit necessary documentation on applications, such as Social Security numbers and immigration details. 
READ MORE >

Physician left to pay hospital’s $313K legal tab after lawsuit over peer review process fizzles

In a complaint, a California doctor accused his former employer and colleagues of making false statements to damage his reputation. The hospital argued, successfully, that the internist failed to exhaust internal dispute resolution procedures that could have stopped him from losing income.

READ MORE >
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Physician left to pay hospital’s $313K legal tab after lawsuit over peer review process fizzles

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In a complaint, a California doctor accused his former employer and colleagues of making false statements to damage his reputation. The hospital argued, successfully, that the internist failed to exhaust internal dispute resolution procedures that could have stopped him from losing income.
READ MORE >

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