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Patient's death prompts new FDA warning | Previewing ESC 2025 | Multiple Class I recalls | Palliative care's impact

News You Need to Know Today
Patient's death prompts new FDA warning | Previewing ESC 2025 | Multiple Class I recalls | Palliative care's impact
Friday, August 29, 2025
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Editor's Choice: Heart Failure

FDA details new risk with Johnson & Johnson heart pump controllers after patient’s death

This latest alert was put in place after Johnson & Johnson MedTech learned that some of its Automated Impella Controllers were built to the wrong specifications, impacting their ability to function. Affected devices should not be used going forward.

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Johnson & Johnson MedTech Automated Impella Controller
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FDA details new risk with Johnson & Johnson heart pump controllers after patient’s death

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Johnson & Johnson MedTech Automated Impella Controller
This latest alert was put in place after Johnson & Johnson MedTech learned that some of its Automated Impella Controllers were built to the wrong specifications, impacting their ability to function. Affected devices should not be used going forward.
READ MORE >

The most anticipated trials at ESC 2025

The European Society of Cardiology 2025 congress includes 10 Hot Line sessions and 28 late-breaking science sessions to showcase the latest science.

READ MORE >
The European Society of Cardiology 2025 congress includes 10 Hot Line sessions and 28 late-breaking science sessions to showcase the latest science.ESC Congress 2022 European Society of Cardiology. #ESC #ESC2025 #ESC25
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The most anticipated trials at ESC 2025

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The European Society of Cardiology 2025 congress includes 10 Hot Line sessions and 28 late-breaking science sessions to showcase the latest science.ESC Congress 2022 European Society of Cardiology. #ESC #ESC2025 #ESC25
The European Society of Cardiology 2025 congress includes 10 Hot Line sessions and 28 late-breaking science sessions to showcase the latest science.
READ MORE >

FDA clears wearable heart device that captures multiple signals at once

The newly approved device captures electrocardiogram, photoplethysmogram and seismocardiogram signals at the same time. It can also be paired with advanced AI models to monitor patients for specific conditions.

READ MORE >
Cardiosense CardioTag
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FDA clears wearable heart device that captures multiple signals at once

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Cardiosense CardioTag
The newly approved device captures electrocardiogram, photoplethysmogram and seismocardiogram signals at the same time. It can also be paired with advanced AI models to monitor patients for specific conditions.
READ MORE >

FDA announces Class I recalls for heart pump accessories due to safety risk

Abbott has warned healthcare providers about a new issue with the mobile power units of certain HeartMate 3 LVADs. 

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Recall | Product recall
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FDA announces Class I recalls for heart pump accessories due to safety risk

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Recall | Product recall
Abbott has warned healthcare providers about a new issue with the mobile power units of certain HeartMate 3 LVADs. 
READ MORE >

FDA announces Class I recall due to heart pump controller issue

The FDA previously shared an early alert about this issue, but it was still reviewing the situation at the time. The new recall covers a total of more than 11,000 devices.

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Product Recall
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FDA announces Class I recall due to heart pump controller issue

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Product Recall
The FDA previously shared an early alert about this issue, but it was still reviewing the situation at the time. The new recall covers a total of more than 11,000 devices.
READ MORE >

Cardiovascular device approvals continue to lead the FDA's Breakthrough Device Program

Cardiology is number one in FDA Breakthrough Device designations at 218, the highest number out of all other clinical categories. This includes 16 new devices cleared in the past year.

READ MORE >
The U.S. Food and Drug Administration (FDA) updated the Breakthrough Device Program designations data this week, which now includes 1,176 Breakthrough Device designations, of which 160 have gained market clearance. Cardiovascular devices lead these with 243 devices, the highest number out of all other clinical categories. This includes 16 new cardiovascular devices cleared in the past year.
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Cardiovascular device approvals continue to lead the FDA's Breakthrough Device Program

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The U.S. Food and Drug Administration (FDA) updated the Breakthrough Device Program designations data this week, which now includes 1,176 Breakthrough Device designations, of which 160 have gained market clearance. Cardiovascular devices lead these with 243 devices, the highest number out of all other clinical categories. This includes 16 new cardiovascular devices cleared in the past year.
Cardiology is number one in FDA Breakthrough Device designations at 218, the highest number out of all other clinical categories. This includes 16 new devices cleared in the past year.
READ MORE >

Palliative care plays an essential role in heart failure care

New HFSA recommendations highlight the importance of integrating palliative care into the day-to-day care of heart failure patients.

READ MORE >
Senior Patient
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Palliative care plays an essential role in heart failure care

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Senior Patient
New HFSA recommendations highlight the importance of integrating palliative care into the day-to-day care of heart failure patients.
READ MORE >

Algorithm brings early heart failure screening to primary care office visits

Most patients are first diagnosed with heart failure in an emergency room or hospital, when their symptoms are already severe. This advanced algorithm could change all that by opening up screening to many more patients. 

READ MORE >
The Ventric Health Vivio AI system screens for elevated left ventricular end-diastolic pressure, or filling pressure (LVEDP) quickly with a a five-minute, noninvasive test using a blood pressure cuff, single-lead Bluetooth-enabled ECG, and proprietary algorithm. This can be performed in a single primary care office visit.
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Algorithm brings early heart failure screening to primary care office visits

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The Ventric Health Vivio AI system screens for elevated left ventricular end-diastolic pressure, or filling pressure (LVEDP) quickly with a a five-minute, noninvasive test using a blood pressure cuff, single-lead Bluetooth-enabled ECG, and proprietary algorithm. This can be performed in a single primary care office visit.
Most patients are first diagnosed with heart failure in an emergency room or hospital, when their symptoms are already severe. This advanced algorithm could change all that by opening up screening to many more patients. 
READ MORE >

Air purifiers may reduce cardiovascular risks from pollution and wildfires

Multiple studies in recent years have linked poor air quality to significant cardiac risks. Air filters, however, have shown potential to help combat these risks.

READ MORE >
Wildfire pollution image. Photo courtesy of the American Heart Association.
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Air purifiers may reduce cardiovascular risks from pollution and wildfires

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Wildfire pollution image. Photo courtesy of the American Heart Association.
Multiple studies in recent years have linked poor air quality to significant cardiac risks. Air filters, however, have shown potential to help combat these risks.
READ MORE >

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