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Semaglutide & frail heart failure patients | AI turns mammograms into CVD risk assessments | Regeneron gains a key FDA approval

News You Need to Know Today
Semaglutide & frail heart failure patients | AI turns mammograms into CVD risk assessments | Regeneron gains a key FDA approval
Tuesday, September 30, 2025
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Today's News and Trends

Vulnerable, but treatable: Semaglutide reduces symptoms in high-risk heart failure patients

Yes, even frail HFpEF patients see significant benefits when treated with semaglutide. Researchers believe these new data may help ease the minds of cardiologists everywhere.

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Elderly patient doctor. Despite an expanded indication from the FDA and lower prices, patient access to these cholesterol-lowering medications remains a significant issue.
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Vulnerable, but treatable: Semaglutide reduces symptoms in high-risk heart failure patients

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Elderly patient doctor. Despite an expanded indication from the FDA and lower prices, patient access to these cholesterol-lowering medications remains a significant issue.
Yes, even frail HFpEF patients see significant benefits when treated with semaglutide. Researchers believe these new data may help ease the minds of cardiologists everywhere.
READ MORE >

AI turns mammograms into CVD risk assessments—no outside data required

Thanks to AI, clinicians can use mammograms to do a lot more than identify signs of breast cancer. Researchers explored data from nearly 50,000 patients, presenting their findings in Heart.

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mammogram mammography breast cancer
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AI turns mammograms into CVD risk assessments—no outside data required

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mammogram mammography breast cancer
Thanks to AI, clinicians can use mammograms to do a lot more than identify signs of breast cancer. Researchers explored data from nearly 50,000 patients, presenting their findings in Heart.
READ MORE >

FDA approves treatment of rare genetic disorder in children as young as 1 year old

Evinacumab-dgnb, sold by Regeneron under the brand name Evkeeza, can now be used to treat homozygous familial hypercholesterolemia in much younger patients.

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Evinacumab-dgnb is sold by Regeneron under the brand name Evkeeza
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FDA approves treatment of rare genetic disorder in children as young as 1 year old

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Evinacumab-dgnb is sold by Regeneron under the brand name Evkeeza
Evinacumab-dgnb, sold by Regeneron under the brand name Evkeeza, can now be used to treat homozygous familial hypercholesterolemia in much younger patients.
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Featured Articles

U.S. considering new tariffs for heart valves, imaging equipment and other medical devices

The Department of Commerce is seeking more information about how current trade policies are impacting the U.S. medtech industry. The investigation could lead to the creation of new tariffs. Public comments are being accepted until Oct. 17, and the findings will be presented to President Donald Trump.

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U.S. considering new tariffs for heart valves, imaging equipment and other medical devices

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The Department of Commerce is seeking more information about how current trade policies are impacting the U.S. medtech industry. The investigation could lead to the creation of new tariffs. Public comments are being accepted until Oct. 17, and the findings will be presented to President Donald Trump.
READ MORE >

AI delivers helpful heart health advice—but not every time

AI-powered chatbots can be valuable resources when users have questions about cardiovascular health—but they are still far from perfect.

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robot reviewing heart data
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AI delivers helpful heart health advice—but not every time

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robot reviewing heart data
AI-powered chatbots can be valuable resources when users have questions about cardiovascular health—but they are still far from perfect.
READ MORE >

Mavacamten fails to boost outcomes for patients with nonobstructive HCM

The drug, already approved by the FDA to treat obstructive HCM, failed to outperform a placebo after 48 weeks.

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pharmaceutical drug approval process
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Mavacamten fails to boost outcomes for patients with nonobstructive HCM

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pharmaceutical drug approval process
The drug, already approved by the FDA to treat obstructive HCM, failed to outperform a placebo after 48 weeks.
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In Case You Missed It

Multimodality imagers play a critical role in modern heart teams

Heart teams continue to play a major role at hospitals and health systems all over the world. Cardiac imagers who have trained in multiple modalities can provide those teams with a significant amount of value.

READ MORE >
Wael Jaber, MD, chair of the 2025 American Society of Nuclear Cardiology (ASNC) annual meeting, director of nuclear cardiology and a professor of medicine at Cleveland Clinic, spoke at a session on the role of cardiac imagers on the heart team. #ASNC
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Multimodality imagers play a critical role in modern heart teams

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Wael Jaber, MD, chair of the 2025 American Society of Nuclear Cardiology (ASNC) annual meeting, director of nuclear cardiology and a professor of medicine at Cleveland Clinic, spoke at a session on the role of cardiac imagers on the heart team. #ASNC
Heart teams continue to play a major role at hospitals and health systems all over the world. Cardiac imagers who have trained in multiple modalities can provide those teams with a significant amount of value.
READ MORE >

FDA clears Apple Watch algorithm for detecting hypertension

The FDA’s decision arrived just days after Apple announced the new feature. "This tool empowers patients and clinicians to work together, putting prevention at the center of care," one cardiologist told Cardiovascular Business. 

READ MORE >
The U.S. Food and Drug Administration (FDA) cleared a smart watch artificial intelligence (AI) algorithm that tells wearers if they are suspected of having hypertension, which is expected to help notify about 1 million users over the next year. This a is a new feature of the newly launched Apple Watch Ultra 3, which the company unveiled Sept. 9. Apple gained FDA for its Cardiovascular Machine Learning-Based Notification Software Hypertension Notification Feature (HTNF) Sept. 11, 2025.
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FDA clears Apple Watch algorithm for detecting hypertension

Share on Twitter Share on Facebook Share on Linkedin
The U.S. Food and Drug Administration (FDA) cleared a smart watch artificial intelligence (AI) algorithm that tells wearers if they are suspected of having hypertension, which is expected to help notify about 1 million users over the next year. This a is a new feature of the newly launched Apple Watch Ultra 3, which the company unveiled Sept. 9. Apple gained FDA for its Cardiovascular Machine Learning-Based Notification Software Hypertension Notification Feature (HTNF) Sept. 11, 2025.
The FDA’s decision arrived just days after Apple announced the new feature. "This tool empowers patients and clinicians to work together, putting prevention at the center of care," one cardiologist told Cardiovascular Business. 
READ MORE >

Shockwave Medical launches new IVL catheter for challenging lesions in Europe

The balloon-free catheter, which already had a successful launch in the United States, has been associated with positive outcomes and the ability to reach certain lesions more accurately than balloon-based IVL platforms.

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Shockwave Medical Javelin Peripheral IVL Catheter
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Shockwave Medical launches new IVL catheter for challenging lesions in Europe

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Shockwave Medical Javelin Peripheral IVL Catheter
The balloon-free catheter, which already had a successful launch in the United States, has been associated with positive outcomes and the ability to reach certain lesions more accurately than balloon-based IVL platforms.
READ MORE >

In Other News

Does BMI affect AI's accuracy when assessing CT scans?

AI is only as effective as the data it was trained on, and many datasets lack diversity in terms of patient body mass index.

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Obesity Paradox Body Mass Index
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Does BMI affect AI's accuracy when assessing CT scans?

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Obesity Paradox Body Mass Index
AI is only as effective as the data it was trained on, and many datasets lack diversity in terms of patient body mass index.
READ MORE >

Fewer than 30% of FDA-cleared AI devices share key safety, adverse event info prior to approval

A new analysis is prompting questions regarding how rigorously many of the AI-enabled tools approved by the U.S. Food and Drug Administration are evaluated prior to their clearance. 

READ MORE >
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Fewer than 30% of FDA-cleared AI devices share key safety, adverse event info prior to approval

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A new analysis is prompting questions regarding how rigorously many of the AI-enabled tools approved by the U.S. Food and Drug Administration are evaluated prior to their clearance. 
READ MORE >

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