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FDA clears first OTC cuffless blood pressure monitor | Early occlusion after CABG | Statins linked to a new potential benefit

News You Need to Know Today
FDA clears first OTC cuffless blood pressure monitor | Early occlusion after CABG | Statins linked to a new potential benefit
Thursday, July 10, 2025
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Today's News and Trends

‘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

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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 >

Early occlusion after CABG much more likely for female patients

Care teams should be aware of this difference, even using CT images when possible to look for signs of any potential issues.

READ MORE >
old woman or doctor shaking hands with patient
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Early occlusion after CABG much more likely for female patients

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old woman or doctor shaking hands with patient
Care teams should be aware of this difference, even using CT images when possible to look for signs of any potential issues.
READ MORE >

Statin use may protect patients from subarachnoid hemorrhages

Statins appear to be the most impactful for patients diagnosed with hypertension or cerebrovascular disease.

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Continuous and high-adherent statin users had lower baseline arterial stiffness which also grew more slowly over time, a new JAMA Network Open study finds.
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Statin use may protect patients from subarachnoid hemorrhages

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Continuous and high-adherent statin users had lower baseline arterial stiffness which also grew more slowly over time, a new JAMA Network Open study finds.
Statins appear to be the most impactful for patients diagnosed with hypertension or cerebrovascular disease.
READ MORE >

Featured Articles

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 >

With MPFS proposal on the way, electrophysiology groups outline their priorities

The Heart Rhythm Society and its new advocacy arm plan on pushing CMS to include certain policy improvements in the 2026 MPFS.

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Congress in Washington, D.C., is working on legislation to possibly expand Medicare coverage payments for phjysicians.
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With MPFS proposal on the way, electrophysiology groups outline their priorities

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Congress in Washington, D.C., is working on legislation to possibly expand Medicare coverage payments for phjysicians.
The Heart Rhythm Society and its new advocacy arm plan on pushing CMS to include certain policy improvements in the 2026 MPFS.
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. 
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In Case You Missed It

FDA declares Class I recall on heart surgery procedure kits from Medline

The news is related to an earlier recall of more than 316,000 Medtronic devices.

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the words "FDA recall" on a board
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FDA declares Class I recall on heart surgery procedure kits from Medline

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the words "FDA recall" on a board
The news is related to an earlier recall of more than 316,000 Medtronic devices.
READ MORE >

Johnson & Johnson MedTech faces threat of permanent injunction after losing antitrust case

After being ordered to pay $442 million in damages—a ruling the company has said it may appeal—Johnson & Johnson MedTech is now facing the possibility of a permanent injunction that could impact certain business practices. A hearing is scheduled for July. 

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statue justice legal verdict malpractice case lawsuit scale
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Johnson & Johnson MedTech faces threat of permanent injunction after losing antitrust case

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statue justice legal verdict malpractice case lawsuit scale
After being ordered to pay $442 million in damages—a ruling the company has said it may appeal—Johnson & Johnson MedTech is now facing the possibility of a permanent injunction that could impact certain business practices. A hearing is scheduled for July. 
READ MORE >

American College of Cardiology now supports early use of medication to treat obesity

The group highlighted the proven effectiveness of these drugs, especially semaglutide and tirzepatide, while noting that eligibility, affordability and availability will still play key roles in any treatment decisions. 

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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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American College of Cardiology now supports early use of medication to treat obesity

Share on Twitter Share on Facebook Share on Linkedin
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]
The group highlighted the proven effectiveness of these drugs, especially semaglutide and tirzepatide, while noting that eligibility, affordability and availability will still play key roles in any treatment decisions. 
READ MORE >

In Other News

Lawmakers propose allowing radiologists to own hospitals, drawing ire from industry lobbying group

“Patients should have the freedom to choose the highest quality care available, and physicians should be allowed to provide it,” said Rep. Beth Van Duyne, R-Texas. 

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Congresswoman Rep Beth Van Duyne
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Lawmakers propose allowing radiologists to own hospitals, drawing ire from industry lobbying group

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Congresswoman Rep Beth Van Duyne
“Patients should have the freedom to choose the highest quality care available, and physicians should be allowed to provide it,” said Rep. Beth Van Duyne, R-Texas. 
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Low-intensity focused ultrasound a noninvasive treatment option for lingering COVID symptoms

New research suggests the technique can effectively break down amyloid fibrinogen microclots, which are believed to interfere with perfusion and cause inflammation.

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surgical mask
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Low-intensity focused ultrasound a noninvasive treatment option for lingering COVID symptoms

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surgical mask
New research suggests the technique can effectively break down amyloid fibrinogen microclots, which are believed to interfere with perfusion and cause inflammation.
READ MORE >

Industry News

 

Biome Analytics launches Biome IMPACT, a first-of-its-kind AI-enabled framework to automate and accelerate cardiovascular performance improvement

Biome Analytics has launched Biome IMPACT, a new AI-enabled methodology to support cardiovascular performance improvement. The framework helps health systems identify opportunities, align stakeholders and track measurable results—without adding to the team’s workload.  
READ MORE >
 

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