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FDA clears OTC cuffless BP monitor | Cardiologist killed | New heart pump implanted for first time | Medicare covers TriClip

News You Need to Know Today
FDA clears OTC cuffless BP monitor | Cardiologist killed | New heart pump implanted for first time | Medicare covers TriClip
Saturday, July 12, 2025
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This Week’s News

‘The start of a paradigm shift’: FDA clears first over-the-counter cuffless blood pressure monitor

The cuffless technology, which has already gained CE mark approval, should make its U.S. debut in 2026.

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aktiia hilo band cuffless blood pressure monitor
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‘The start of a paradigm shift’: FDA clears first over-the-counter cuffless blood pressure monitor

Share on Twitter Share on Facebook Share on Linkedin
aktiia hilo band cuffless blood pressure monitor
The cuffless technology, which has already gained CE mark approval, should make its U.S. debut in 2026.
READ MORE >

Beloved cardiologist killed in airstrike—he was one of Gaza’s last heart doctors

A prominent doctor and multiple family members are dead after an Israeli airstrike. "Thousands of heart patients will suffer as a result of his killing," one colleague said.

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Dr. Marwan al-Sultan
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Beloved cardiologist killed in airstrike—he was one of Gaza’s last heart doctors

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Dr. Marwan al-Sultan
A prominent doctor and multiple family members are dead after an Israeli airstrike. "Thousands of heart patients will suffer as a result of his killing," one colleague said.
READ MORE >

FDA expands approval of Boston Scientific’s Farapulse PFA system

The FDA's 2024 approval of the Farapulse system covered patients with paroxysmal atrial fibrillation. Now, however, the technology is officially approved for patients with more persistent symptoms. 

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The Farapulse Boston Scientific Pulsed Field Ablation (PFA) system gained U.S. FDA approval in early 2024.
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FDA expands approval of Boston Scientific’s Farapulse PFA system

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The Farapulse Boston Scientific Pulsed Field Ablation (PFA) system gained U.S. FDA approval in early 2024.
The FDA's 2024 approval of the Farapulse system covered patients with paroxysmal atrial fibrillation. Now, however, the technology is officially approved for patients with more persistent symptoms. 
READ MORE >

World’s first patient receives new-look heart pump—cardiologist ‘impressed’ by device’s performance

The CorWave technology is unlike other left ventricular assist devices, working in harmony with the patient's heartbeat and making adjustments as needed. 

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CorWave LVAD
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World’s first patient receives new-look heart pump—cardiologist ‘impressed’ by device’s performance

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CorWave LVAD
The CorWave technology is unlike other left ventricular assist devices, working in harmony with the patient's heartbeat and making adjustments as needed. 
READ MORE >

Medicare now covers TriClip procedures for patients with symptomatic tricuspid regurgitation

CMS has finalized a new national coverage determination for T-TEER, sometimes known as transcatheter tricuspid valve repair. Abbott's TriClip is the only device approved by the FDA for T-TEER, but other treatment options are under development.

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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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Medicare now covers TriClip procedures for patients with symptomatic tricuspid regurgitation

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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.
CMS has finalized a new national coverage determination for T-TEER, sometimes known as transcatheter tricuspid valve repair. Abbott's TriClip is the only device approved by the FDA for T-TEER, but other treatment options are under development.
READ MORE >

Cardiology still No. 2 in FDA-cleared clinical AI algorithms, trailing only radiology

Cardiology continues to be one of the most influential healthcare specialties when it comes to utilizing artificial intelligence. 

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An example of artificial intelligence automated coronary artery calcium scoring shown by Coreline at ACC23. The AI also identifies and color codes the anatomy so help show the reviewing radiologist or cardiac imager what and where things were calculated. #ACC #ACC23
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Cardiology still No. 2 in FDA-cleared clinical AI algorithms, trailing only radiology

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An example of artificial intelligence automated coronary artery calcium scoring shown by Coreline at ACC23. The AI also identifies and color codes the anatomy so help show the reviewing radiologist or cardiac imager what and where things were calculated. #ACC #ACC23
Cardiology continues to be one of the most influential healthcare specialties when it comes to utilizing artificial intelligence. 
READ MORE >

FDA grants breakthrough therapy designation to new drug candidate for FA cardiomyopathy

The new drug, LX2006, has already received the FDA's fast track designation. This latest distinction was based on early data from two separate clinical trials.

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heart drugs with stethoscope
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FDA grants breakthrough therapy designation to new drug candidate for FA cardiomyopathy

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heart drugs with stethoscope
The new drug, LX2006, has already received the FDA's fast track designation. This latest distinction was based on early data from two separate clinical trials.
READ MORE >

New TAVR valve from MiRus linked to positive early outcomes

The Siegel TAVR valve includes no nickel or cobalt. In fact, its frame was built using special alloys specifically developed by MiRus. 

READ MORE >
MiRus Siegel TAVR valve includes no nickel or cobalt. In fact, its frame was built using special alloys specifically developed by MiRus.
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New TAVR valve from MiRus linked to positive early outcomes

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MiRus Siegel TAVR valve includes no nickel or cobalt. In fact, its frame was built using special alloys specifically developed by MiRus.
The Siegel TAVR valve includes no nickel or cobalt. In fact, its frame was built using special alloys specifically developed by MiRus. 
READ MORE >

Radiation in the cath lab: Tracking state-level regulations for cardiologists

Researchers hope these policies can be standardized in the future to help avoid confusion and improve clinician safety.

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USA
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Radiation in the cath lab: Tracking state-level regulations for cardiologists

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USA
Researchers hope these policies can be standardized in the future to help avoid confusion and improve clinician safety.
READ MORE >

Medical malpractice lawsuits are rare in sports cardiology—but they can cost providers millions

When doctors are accused of mishandling the heart health of a young athlete, it occasionally ends up being settled in a courtroom. 

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Judge bangs gavel
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Medical malpractice lawsuits are rare in sports cardiology—but they can cost providers millions

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Judge bangs gavel
When doctors are accused of mishandling the heart health of a young athlete, it occasionally ends up being settled in a courtroom. 
READ MORE >

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