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News You Need to Know Today
Week in Review: Doc sues hospital | New device recalls | FDA clears Apple algorithm for hypertension | AI's potential
Saturday, September 20, 2025
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This Week’s News

Cardiologist sues hospital after he was allegedly let go for sharing safety concerns

The veteran interventional cardiologist claims he was pushed out after repeatedly asking for more coverage from cardiothoracic surgeons in addition to other improvements. The hospital, meanwhile, described the lawsuit as a “collection of false allegations."

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A gavel and a stethoscope
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Cardiologist sues hospital after he was allegedly let go for sharing safety concerns

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A gavel and a stethoscope
The veteran interventional cardiologist claims he was pushed out after repeatedly asking for more coverage from cardiothoracic surgeons in addition to other improvements. The hospital, meanwhile, described the lawsuit as a “collection of false allegations."
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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Dexcom issues new recall for CGM apps due to safety risk—users urged to update immediately

The FDA has categorized this as a Class I recall. If patients update their phone or watch apps as needed, they can continue to use these devices like normal.

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The Dexcom G7 Continuous Glucose Monitoring System
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Dexcom issues new recall for CGM apps due to safety risk—users urged to update immediately

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The Dexcom G7 Continuous Glucose Monitoring System
The FDA has categorized this as a Class I recall. If patients update their phone or watch apps as needed, they can continue to use these devices like normal.
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. 

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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 >

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 >

New registry helps hospitals expand outpatient services for heart patients

The initiation of the ACC Ambulatory Surgical Center Registry comes at a time when hospitals are expanding their structural heart programs. The registry is providing valuable details about which patients should stay at the hospital and which can be treated in an outpatient setting.

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Joan Michaels, RN, director of the American College of Cardiology (ACC) National Cardiovascular Data Registry (NCDR) Transcatheter Valve Therapies (TVT) and IMPACT congenital heart registries, said the addition of the ambulatory surgical center (ASC) registry comes at a time when hospitals are expanding structural heart programs and ASC's will likely play a growing role to help free up more hospital cath labs for the more complex cases.
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New registry helps hospitals expand outpatient services for heart patients

Share on Twitter Share on Facebook Share on Linkedin
Joan Michaels, RN, director of the American College of Cardiology (ACC) National Cardiovascular Data Registry (NCDR) Transcatheter Valve Therapies (TVT) and IMPACT congenital heart registries, said the addition of the ambulatory surgical center (ASC) registry comes at a time when hospitals are expanding structural heart programs and ASC's will likely play a growing role to help free up more hospital cath labs for the more complex cases.
The initiation of the ACC Ambulatory Surgical Center Registry comes at a time when hospitals are expanding their structural heart programs. The registry is providing valuable details about which patients should stay at the hospital and which can be treated in an outpatient setting.
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 >

Abbott warns EP labs the tip can detach from its TactiFlex ablation catheters

Improper removal of the catheter from the packaging can result in tip damage. Most damaged tips were detected prior to being used, but three tips did separate inside patients.
 

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Abbott has recalled its TactiFlex Ablation Catheter, Sensor Enabled, because of reports that the tip can separate.
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Abbott warns EP labs the tip can detach from its TactiFlex ablation catheters

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Abbott has recalled its TactiFlex Ablation Catheter, Sensor Enabled, because of reports that the tip can separate.
Improper removal of the catheter from the packaging can result in tip damage. Most damaged tips were detected prior to being used, but three tips did separate inside patients. 
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 >

Heart surgeons see more potential in AI than colleagues from other fields

Cardiac surgeons see significant value in AI's ability to assist clinicians with administrative tasks and patient selection. When it comes to making clinical decisions, however, there is still a certain amount of skepticism. 

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AI healthcare doctor surgery procedure artificial intelligence
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Heart surgeons see more potential in AI than colleagues from other fields

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AI healthcare doctor surgery procedure artificial intelligence
Cardiac surgeons see significant value in AI's ability to assist clinicians with administrative tasks and patient selection. When it comes to making clinical decisions, however, there is still a certain amount of skepticism. 
READ MORE >

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