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News You Need to Know Today
Medline recalls surgical kits | Rethinking device approvals in Europe | FDA approves nasal spray for HF-related edema
Wednesday, September 17, 2025
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Today's News and Trends

Medline recalls surgical kits due to safety concern with Medtronic catheters

The FDA is warning the public that certain Medline surgical kits may contain catheters that have been linked to 41 customer complaints and three serious injuries. 

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Product Recall
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Medline recalls surgical kits due to safety concern with Medtronic catheters

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Product Recall
The FDA is warning the public that certain Medline surgical kits may contain catheters that have been linked to 41 customer complaints and three serious injuries. 
READ MORE >

Cardiologists lead charge for medical device approvals in Europe to be more rigorous

There is a belief among some clinicians that it is too easy for companies to gain CE mark approval for their medical devices. However, a new proposal from the European Society of Cardiology and other groups could help change that. 

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All medical device products in Europe need to obtain the Conformité Européenne mark (European Conformity, or CE mark) regulatory approval. This is based on minimal safety requirements and is needed to be sold in the EU.
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Cardiologists lead charge for medical device approvals in Europe to be more rigorous

Share on Twitter Share on Facebook Share on Linkedin
All medical device products in Europe need to obtain the Conformité Européenne mark (European Conformity, or CE mark) regulatory approval. This is based on minimal safety requirements and is needed to be sold in the EU.
There is a belief among some clinicians that it is too easy for companies to gain CE mark approval for their medical devices. However, a new proposal from the European Society of Cardiology and other groups could help change that. 
READ MORE >

FDA approves nasal spray for edema associated with congestive heart failure

The newly approved intranasal loop diuretic can also be used to treat edema in patients with liver and kidney disease.

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Corstasis Therapeutics bumetanide nasal spray Enbumyst
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FDA approves nasal spray for edema associated with congestive heart failure

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Corstasis Therapeutics bumetanide nasal spray Enbumyst
The newly approved intranasal loop diuretic can also be used to treat edema in patients with liver and kidney disease.
READ MORE >

Featured Articles

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. 

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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

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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 >

Update: FDA confirms recalls for defibrillation leads after nearly 400 injuries

Safety concerns with certain Boston Scientific leads have resulted in multiple Class I recalls, the FDA has announced. The agency first shared a warning about this issue in August. 

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Recall | Product recall
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Update: FDA confirms recalls for defibrillation leads after nearly 400 injuries

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Recall | Product recall
Safety concerns with certain Boston Scientific leads have resulted in multiple Class I recalls, the FDA has announced. The agency first shared a warning about this issue in August. 
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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.

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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
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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 >

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 Case You Missed It

How to address CCTA staffing shortages

Jaime Warren, EdD, FACC, vice president of care transformation at MedAxiom, an ACC company, explains what is needed to address staffing shortages created by a 94% increase in cardiac CT volumes over the past 5 years. 

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Jaime Warren, EdD, FACC, vice president of care transformation at MedAxiom, an ACC company, explains what is needed to address staffing shortages created by a 94% increase in cardiac CT volumes over the past 5 years.
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How to address CCTA staffing shortages

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Jaime Warren, EdD, FACC, vice president of care transformation at MedAxiom, an ACC company, explains what is needed to address staffing shortages created by a 94% increase in cardiac CT volumes over the past 5 years.
Jaime Warren, EdD, FACC, vice president of care transformation at MedAxiom, an ACC company, explains what is needed to address staffing shortages created by a 94% increase in cardiac CT volumes over the past 5 years. 
READ MORE >

Medtronic’s RDN system approved in Japan

Hypertension is a significant issue in Japan, impacting an estimated 43 million adults. Medtronic's Symplicity Spyral RDN system is now approved for the treatment of those patients. 

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Medtronic Symplicity Spyral renal denervation
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Medtronic’s RDN system approved in Japan

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Medtronic Symplicity Spyral renal denervation
Hypertension is a significant issue in Japan, impacting an estimated 43 million adults. Medtronic's Symplicity Spyral RDN system is now approved for the treatment of those patients. 
READ MORE >

ESC Congress broke new record with over 33,000 attendees

The European Society of Cardiology had nearly twice as many attendees as ACC this year, as the European meeting secures its place as the largest cardiology meeting in the world.

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The European Society of Cardiology (ESC) annual congress has become the largest cardiology in the world with more than 33,000 healthcare professionals at the 2025 meeting. Photo by ESC
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ESC Congress broke new record with over 33,000 attendees

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The European Society of Cardiology (ESC) annual congress has become the largest cardiology in the world with more than 33,000 healthcare professionals at the 2025 meeting. Photo by ESC
The European Society of Cardiology had nearly twice as many attendees as ACC this year, as the European meeting secures its place as the largest cardiology meeting in the world.
READ MORE >

In Other News

11% of U.S. adults were uninsured in 2024, Census data shows

Newly released data from the U.S. Census Bureau shows most Americans still rely on work for their health coverage, with 53.8% of insured Americans receiving coverage through their employer.

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Insurance stock photo
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11% of U.S. adults were uninsured in 2024, Census data shows

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Insurance stock photo
Newly released data from the U.S. Census Bureau shows most Americans still rely on work for their health coverage, with 53.8% of insured Americans receiving coverage through their employer.
READ MORE >

MGMA: Ending ACA subsidies could strain health system, leave millions uninsured

Anders Gilberg, senior vice president of government affairs at the Medical Group Management Association, explains the political and patient care issues involved with ending Affordable Care Act subsidies.

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Video interview with Anders Gilberg, MGA, senior vice president, government affairs at Medical Group Management Association (MGMA), explains the issues involved with the Affordable Care Act (ACA) subsidies that are set to end in late 2025 and what the impact will be on hospitals.
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MGMA: Ending ACA subsidies could strain health system, leave millions uninsured

Share on Twitter Share on Facebook Share on Linkedin
Video interview with Anders Gilberg, MGA, senior vice president, government affairs at Medical Group Management Association (MGMA), explains the issues involved with the Affordable Care Act (ACA) subsidies that are set to end in late 2025 and what the impact will be on hospitals.
Anders Gilberg, senior vice president of government affairs at the Medical Group Management Association, explains the political and patient care issues involved with ending Affordable Care Act subsidies.
READ MORE >

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