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News You Need to Know Today
Heart devices sending delayed alerts | FDA clears imaging software | Stroke recommendations | Sugar substitute linked to risks
Friday, September 4, 2026
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Today's News and Trends

FDA finalizes recall due to heart devices sending delayed alerts—software update on the way

Boston Scientific is warning clinicians about an ongoing safety concern with its LUX-Dx family of insertable cardiac monitors. No devices need to be returned or replaced, but the FDA did finalize a Class II recall. 

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Boston Scientific LUX-Dx ICM
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FDA finalizes recall due to heart devices sending delayed alerts—software update on the way

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Boston Scientific LUX-Dx ICM
Boston Scientific is warning clinicians about an ongoing safety concern with its LUX-Dx family of insertable cardiac monitors. No devices need to be returned or replaced, but the FDA did finalize a Class II recall. 
READ MORE >

Stroke patients should start rehab as soon as possible

Stroke patients should begin their road to recovery as soon as they are medically stable, according to a new ASA/AHA guideline. In fact, starting within the first 48 hours is recommended to maximize the patient’s chance of a full recovery.

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stroke
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Stroke patients should start rehab as soon as possible

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stroke
Stroke patients should begin their road to recovery as soon as they are medically stable, according to a new ASA/AHA guideline. In fact, starting within the first 48 hours is recommended to maximize the patient’s chance of a full recovery.
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FDA clears new imaging software from AI company founded by cardiologists

The new software from Tennessee-based Heartvue.ai uses advanced AI algorithms to view, process and evaluate cardiac MRI scans. It was built to work with any existing cardiology or radiology workflow.

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artificial intelligence AI predictive analytics
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FDA clears new imaging software from AI company founded by cardiologists

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artificial intelligence AI predictive analytics
The new software from Tennessee-based Heartvue.ai uses advanced AI algorithms to view, process and evaluate cardiac MRI scans. It was built to work with any existing cardiology or radiology workflow.
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.
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Featured Articles

Why health equity is now a business imperative in cardiology

For health systems under value-based care payment initiatives, there a direct financial incentive to invest in programs that improve access and outcomes among underserved populations. Cardiologist Dipti Itchhaporia, MD, shared her thoughts on this important topic. 

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Former ACC President Dipti Itchhaporia, MD, FACC, an interventional cardiologist, director of cardiovascular innovation , AI and care continuum at Hoag Heart and Vascular Institute, and associate clinical professor at University of California, Irvine, explains why health equity is a clinical and business imperative.
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Why health equity is now a business imperative in cardiology

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Former ACC President Dipti Itchhaporia, MD, FACC, an interventional cardiologist, director of cardiovascular innovation , AI and care continuum at Hoag Heart and Vascular Institute, and associate clinical professor at University of California, Irvine, explains why health equity is a clinical and business imperative.
For health systems under value-based care payment initiatives, there a direct financial incentive to invest in programs that improve access and outcomes among underserved populations. Cardiologist Dipti Itchhaporia, MD, shared her thoughts on this important topic. 
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‘This could be transformative’: Surgeon performs first US implant of heart valve still under FDA review

The size-adjustable pulmonary valve was originally developed by Autus Valve Technologies, which Edwards Lifesciences acquired for $128.9 million. The device was designed to grow with pediatric patients as they age. Clinicians can expand it as necessary with a minimally invasive balloon procedure. 

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Jennifer Romano, MD, MS, a surgeon with at C.S. Mott Children’s Hospital
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‘This could be transformative’: Surgeon performs first US implant of heart valve still under FDA review

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Jennifer Romano, MD, MS, a surgeon with at C.S. Mott Children’s Hospital
The size-adjustable pulmonary valve was originally developed by Autus Valve Technologies, which Edwards Lifesciences acquired for $128.9 million. The device was designed to grow with pediatric patients as they age. Clinicians can expand it as necessary with a minimally invasive balloon procedure. 
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SCCT shares updated CCTA recommendations

A lot has changed in the world of CCTA since the previous guideline was published back in 2014. This new expert consensus document was developed by an international team of imaging experts.

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 The Society of Cardiovascular Computed Tomography (SCCT) this week released a new expert consensus document on interpretation and reporting of coronary CT angiography (CCTA). The update replaced the 2014 guidance and incorporates advances in scanner technology, image reconstruction, plaque assessment and revised standardized reporting incorporating CAD-RADS 2.0. Image in Philips booth at RSNA 2025, photo by Dave Fornell.
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SCCT shares updated CCTA recommendations

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 The Society of Cardiovascular Computed Tomography (SCCT) this week released a new expert consensus document on interpretation and reporting of coronary CT angiography (CCTA). The update replaced the 2014 guidance and incorporates advances in scanner technology, image reconstruction, plaque assessment and revised standardized reporting incorporating CAD-RADS 2.0. Image in Philips booth at RSNA 2025, photo by Dave Fornell.
A lot has changed in the world of CCTA since the previous guideline was published back in 2014. This new expert consensus document was developed by an international team of imaging experts.
READ MORE >

Experts redefine heart attack to improve care for women, get clinicians on the same page

Representatives from ACC, AHA, ESC and WHF worked together to update the universal definition of myocardial infarction. This includes a new classification system that separates events into three categories: primary MI, secondary MI and procedure-related MI. 

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American Heart Association and Joint Commission launch new Comprehensive Heart Attack Center certification.
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Experts redefine heart attack to improve care for women, get clinicians on the same page

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American Heart Association and Joint Commission launch new Comprehensive Heart Attack Center certification.
Representatives from ACC, AHA, ESC and WHF worked together to update the universal definition of myocardial infarction. This includes a new classification system that separates events into three categories: primary MI, secondary MI and procedure-related MI. 
READ MORE >

In Case You Missed It

Popular blood pressure drug recalled

Novartis recalled a single lot of valsartan, a blood pressure/heart failure drug the company sells under the brand name Diovan. According to the FDA, this is a Class II recall.

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Product Recall
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Popular blood pressure drug recalled

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Product Recall
Novartis recalled a single lot of valsartan, a blood pressure/heart failure drug the company sells under the brand name Diovan. According to the FDA, this is a Class II recall.
READ MORE >

Cardiac CT's future could include AI-driven prevention, noncontrast imaging

Structural heart disease is just one of the many areas where cardiac CT is expected to expand in the near future.

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Ed Nicol, MD, FACC, FSCCT, MBA, FRCP, FRCR, FRAeS, head of cardiovascular CT, Royal Brompton Hospital, London, United Kingdom, and former president of the Society of Cardiovascular Computed Tomography (SCCT), explains some of the new technologies being developed to expand cardiac CT as a diagnostic tool.
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Cardiac CT's future could include AI-driven prevention, noncontrast imaging

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Ed Nicol, MD, FACC, FSCCT, MBA, FRCP, FRCR, FRAeS, head of cardiovascular CT, Royal Brompton Hospital, London, United Kingdom, and former president of the Society of Cardiovascular Computed Tomography (SCCT), explains some of the new technologies being developed to expand cardiac CT as a diagnostic tool.
Structural heart disease is just one of the many areas where cardiac CT is expected to expand in the near future.
READ MORE >

FDA clears Bracco’s new ultrasound contrast delivery system for cardiovascular imaging

The VueJect ultrasound contrast delivery system was designed to improve workflow efficiency and provide consistency from one user to the next.

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Bracco Imaging has secured U.S. Food and Drug Administration (FDA) clearance for VueJect, a new ultrasound contrast delivery system built specifically for cardiovascular imaging procedures. This represents the latest addition to Bracco’s contrast-enhanced ultrasound (CEUS) portfolio.
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FDA clears Bracco’s new ultrasound contrast delivery system for cardiovascular imaging

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Bracco Imaging has secured U.S. Food and Drug Administration (FDA) clearance for VueJect, a new ultrasound contrast delivery system built specifically for cardiovascular imaging procedures. This represents the latest addition to Bracco’s contrast-enhanced ultrasound (CEUS) portfolio.
The VueJect ultrasound contrast delivery system was designed to improve workflow efficiency and provide consistency from one user to the next.
READ MORE >

In Other News

HHS announces $77M in grants to curb drug addiction, prevent suicide

The agency said $22 million will be sent to community-based initiatives to aid areas hit hardest by the opioid crisis. 

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Opioids
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HHS announces $77M in grants to curb drug addiction, prevent suicide

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Opioids
The agency said $22 million will be sent to community-based initiatives to aid areas hit hardest by the opioid crisis. 
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AI company scores world’s 1st approval for breast triage tool that skips radiologist review

Vara announced the achievement on Sept. 3, with the Berlin, Germany-based technology firm earning CE Certification under the EU's Medical Device Regulation. 

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AI company scores world’s 1st approval for breast triage tool that skips radiologist review

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Vara announced the achievement on Sept. 3, with the Berlin, Germany-based technology firm earning CE Certification under the EU's Medical Device Regulation. 
READ MORE >

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