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News You Need to Know Today
September's Top Stories: BP drug recalled | Major TAVR changes | AI for heart attack detection | FDA approves small pacemaker
Monday, October 5, 2026
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The Month in Review

Blood pressure drug recalled due to failed test

Specific lots of a popular ACE inhibitor are being recalled after a sample produced an out-of-specification test result. The FDA categorized this issue as a Class II recall. 

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warning safety alert recall healthcare issue
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Blood pressure drug recalled due to failed test

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warning safety alert recall healthcare issue
Specific lots of a popular ACE inhibitor are being recalled after a sample produced an out-of-specification test result. The FDA categorized this issue as a Class II recall. 
READ MORE >

CMS finalizes sweeping TAVR changes, including Medicare coverage for asymptomatic patients

After months of consideration, CMS has officially signed off on major changes to its TAVR policies. The treatment of asymptomatic patients is now covered by Medicare, for example, and fewer reporting requirements are in place when symptomatic patients undergo treatment.

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Heart cardiologists doctors surgery
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CMS finalizes sweeping TAVR changes, including Medicare coverage for asymptomatic patients

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Heart cardiologists doctors surgery
After months of consideration, CMS has officially signed off on major changes to its TAVR policies. The treatment of asymptomatic patients is now covered by Medicare, for example, and fewer reporting requirements are in place when symptomatic patients undergo treatment.
READ MORE >

FDA authorizes ‘Queen of Hearts’ AI model for detecting heart attacks in ECG results

The advanced algorithm, built to detect STEMI and STEMI-equivalent patterns in ECG results, gained the FDA's breakthrough device designation back in 2025.

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AI healthcare doctor surgery procedure artificial intelligence
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FDA authorizes ‘Queen of Hearts’ AI model for detecting heart attacks in ECG results

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AI healthcare doctor surgery procedure artificial intelligence
The advanced algorithm, built to detect STEMI and STEMI-equivalent patterns in ECG results, gained the FDA's breakthrough device designation back in 2025.
READ MORE >

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 >

Stryker recalls AEDs due to malfunction risk

If a malfunction does occur, Stryker warned, it could impact the device's effectiveness. No adverse events have been reported at this time.

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Stryker is recalling nearly 12,000 HeartSine automated external defibrillators (AEDs) due to a risk of the devices failing to deliver the intended therapy. If such a failure does occur, it could lead to therapy being delayed or not being delivered at all.
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Stryker recalls AEDs due to malfunction risk

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Stryker is recalling nearly 12,000 HeartSine automated external defibrillators (AEDs) due to a risk of the devices failing to deliver the intended therapy. If such a failure does occur, it could lead to therapy being delayed or not being delivered at all.
If a malfunction does occur, Stryker warned, it could impact the device's effectiveness. No adverse events have been reported at this time.
READ MORE >

Artificial sweetener linked to much higher risk of heart attack, stroke or death

Xylitol, a sugar substitute found in chewing gum, baked goods and toothpaste, was associated with long-term cardiovascular risks in a new study of more than 17,000 adults.

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chewing gum
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Artificial sweetener linked to much higher risk of heart attack, stroke or death

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chewing gum
Xylitol, a sugar substitute found in chewing gum, baked goods and toothpaste, was associated with long-term cardiovascular risks in a new study of more than 17,000 adults.
READ MORE >

FDA approves smaller leadless pacemaker from Abbott

The newly approved device is 14% shorter than the previous version and gives clinicians more options when making implant decisions.

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The Abbott Aveir VR Mini ventricular leadless pacemaker is a shorter version that gained FDA clearance in 2026.
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FDA approves smaller leadless pacemaker from Abbott

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The Abbott Aveir VR Mini ventricular leadless pacemaker is a shorter version that gained FDA clearance in 2026.
The newly approved device is 14% shorter than the previous version and gives clinicians more options when making implant decisions.
READ MORE >

American Society of Nuclear Cardiology updates cardiac stress testing guideline

The new ASNC document includes detailed SPECT- and PET-specific protocols, patient preparation recommendations and a fresh look at safety.

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Patient set up for a cardiac PET-CT scan at Rush University Medical Center in Chicago. Photo by Dave Fornell. Marilyn Fornell
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American Society of Nuclear Cardiology updates cardiac stress testing guideline

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Patient set up for a cardiac PET-CT scan at Rush University Medical Center in Chicago. Photo by Dave Fornell. Marilyn Fornell
The new ASNC document includes detailed SPECT- and PET-specific protocols, patient preparation recommendations and a fresh look at safety.
READ MORE >

New heart drug from Novartis falls short in clinical trial: ‘Not the results we hoped for’

Pelacarsen, an investigational heart drug developed by Novartis, did successfully reduce Lp(a) levels in high-risk heart patients. However, it was unable to reduce the risk of major adverse cardiovascular events among those patients. 

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cardiologist heart model doctor
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New heart drug from Novartis falls short in clinical trial: ‘Not the results we hoped for’

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cardiologist heart model doctor
Pelacarsen, an investigational heart drug developed by Novartis, did successfully reduce Lp(a) levels in high-risk heart patients. However, it was unable to reduce the risk of major adverse cardiovascular events among those patients. 
READ MORE >

Johnson & Johnson appears to exit LAA closure market, selling heart tech to new startup

Johnson & Johnson is selling key assets related to its Laminar program to a new startup, Jaguar LAA. This comes less than three years after Johnson & Johnson acquired Laminar for $400 million. 

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business handshake
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Johnson & Johnson appears to exit LAA closure market, selling heart tech to new startup

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business handshake
Johnson & Johnson is selling key assets related to its Laminar program to a new startup, Jaguar LAA. This comes less than three years after Johnson & Johnson acquired Laminar for $400 million. 
READ MORE >

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