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FDA clears smart shirt | Did Boston Scientific make the right call on TAVR? | Progress for heart failure drug | Beta-blockers

News You Need to Know Today
FDA clears smart shirt | Did Boston Scientific make the right call on TAVR? | Progress for heart failure drug | Beta-blockers
Friday, November 21, 2025
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Today's News and Trends

FDA clears new ‘smart shirt’ for real-time cardiopulmonary monitoring

According to Hexoskin, the newly cleared technology offers significant value for hospitals and health systems as well as researchers conducting clinical trials. 

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Hexoskin Medical System
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FDA clears new ‘smart shirt’ for real-time cardiopulmonary monitoring

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Hexoskin Medical System
According to Hexoskin, the newly cleared technology offers significant value for hospitals and health systems as well as researchers conducting clinical trials. 
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Did Boston Scientific pull the plug too early on TAVR devices? Cardiologists weigh in

Boston Scientific stopped selling its Acurate TAVR systems after they underperformed in a few key trials and failed to gain FDA approval. Was it the right call?

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Boston Scientific ACURATE neo2 aortic valve system self-expanding TAVR valve.
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Did Boston Scientific pull the plug too early on TAVR devices? Cardiologists weigh in

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Boston Scientific ACURATE neo2 aortic valve system self-expanding TAVR valve.
Boston Scientific stopped selling its Acurate TAVR systems after they underperformed in a few key trials and failed to gain FDA approval. Was it the right call?
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Oral heart failure drug receives FDA’s fast track designation

A clinical trial focused on patients with HFpEF is expected to be completed by July 2026.

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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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Oral heart failure drug receives FDA’s fast track designation

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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]
A clinical trial focused on patients with HFpEF is expected to be completed by July 2026.
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Beta-blockers do not benefit heart attack patients with a normal LVEF

The new meta-analysis included data from nearly 18,000 patients. Overall, patient outcomes were quite similar for patients who did and did not undergo beta-blocker therapy.

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A heart attack is caused when one of the coronary arteries becomes blocked with a clot.
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Beta-blockers do not benefit heart attack patients with a normal LVEF

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A heart attack is caused when one of the coronary arteries becomes blocked with a clot.
The new meta-analysis included data from nearly 18,000 patients. Overall, patient outcomes were quite similar for patients who did and did not undergo beta-blocker therapy.
READ MORE >

Featured Articles

Drones deliver AEDs for the first time in the United States

“This study represents a major step forward in how we respond to cardiac arrest in the United States,” explained Monique Starks, MD, principal investigator. “By integrating drone technology into emergency care, we’re working to close the critical gap between cardiac arrest and treatment."

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Duke University is heading a project that for the first time in the United States, drones will be used to quickly deliver automated external defibrillators (AEDs) to bystanders who call 911 for patients in cardiac arrest. The idea is to deliver an AED faster than police or paramedics could arrive on scene, saving critical minutes in an effort to boost survival.
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Drones deliver AEDs for the first time in the United States

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Duke University is heading a project that for the first time in the United States, drones will be used to quickly deliver automated external defibrillators (AEDs) to bystanders who call 911 for patients in cardiac arrest. The idea is to deliver an AED faster than police or paramedics could arrive on scene, saving critical minutes in an effort to boost survival.
“This study represents a major step forward in how we respond to cardiac arrest in the United States,” explained Monique Starks, MD, principal investigator. “By integrating drone technology into emergency care, we’re working to close the critical gap between cardiac arrest and treatment."
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Early TAVR for asymptomatic severe AS cuts costs, improves outcomes

The study found lifetime per-patient savings from early TAVR ranged from about $2,334 in the U.K. to $19,607 in Switzerland.

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Edwards Lifesciences Sapien 3 TAVR valves at TCT 2024 DF 1
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Early TAVR for asymptomatic severe AS cuts costs, improves outcomes

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Edwards Lifesciences Sapien 3 TAVR valves at TCT 2024 DF 1
The study found lifetime per-patient savings from early TAVR ranged from about $2,334 in the U.K. to $19,607 in Switzerland.
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Device to treat coronary microvascular disease rakes in $23 million in financing

With no treatments available that directly improve INOCA, this breakthrough device offers hope.

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VahatiCor's investigational A-Flux Reducer System helps increase perfusion by restricting the venous flow in the coronary sinus.
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Device to treat coronary microvascular disease rakes in $23 million in financing

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VahatiCor's investigational A-Flux Reducer System helps increase perfusion by restricting the venous flow in the coronary sinus.
With no treatments available that directly improve INOCA, this breakthrough device offers hope.
READ MORE >

In Case You Missed It

FDA panel to review first heart failure device of its kind

The shunt device being reviewed showed a 52% reduction in hospitalizations and favorable trends in mortality in patients with heart failure with reduced ejection fraction. 

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The V-Wave intra-atrial shunt to treat heart failure on display on the expo floor at ACC.24. The device was used in one of the late breaking trials at ACC. DF 3
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FDA panel to review first heart failure device of its kind

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The V-Wave intra-atrial shunt to treat heart failure on display on the expo floor at ACC.24. The device was used in one of the late breaking trials at ACC. DF 3
The shunt device being reviewed showed a 52% reduction in hospitalizations and favorable trends in mortality in patients with heart failure with reduced ejection fraction. 
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Mechanical thrombectomy beats anticoagulation alone in STORM-PE

Highly anticipated trial data comparing mechanical thrombectomy to anticoagulation alone for intermediate- and high-risk pulmonary embolism showed that the more aggressive strategy improved outcomes.

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Video Robert Lookstein on mechanical thrombectomy beating anticoagulation alone in pulmonary embolism in the late-breaking STORM-PE trial at TCT 2025.
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Mechanical thrombectomy beats anticoagulation alone in STORM-PE

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Video Robert Lookstein on mechanical thrombectomy beating anticoagulation alone in pulmonary embolism in the late-breaking STORM-PE trial at TCT 2025.
Highly anticipated trial data comparing mechanical thrombectomy to anticoagulation alone for intermediate- and high-risk pulmonary embolism showed that the more aggressive strategy improved outcomes.
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Mitral annular calcification linked to higher heart failure risks

In fact, researchers wrote, MAC appears to influence a patient's odds of developing HFpEF even more than their BMI.

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heart data research doctor cardiologist AI
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Mitral annular calcification linked to higher heart failure risks

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heart data research doctor cardiologist AI
In fact, researchers wrote, MAC appears to influence a patient's odds of developing HFpEF even more than their BMI.
READ MORE >

In Other News

GE HealthCare to acquire Intelerad for $2.3B

The Chicago-based imaging systems manufacturer said it plans to pay the purchase price in cash, believing the acquisition demonstrates its “continued commitment to cloud-enabled and AI-powered solutions.” 

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GE HealthCare
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GE HealthCare to acquire Intelerad for $2.3B

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GE HealthCare
The Chicago-based imaging systems manufacturer said it plans to pay the purchase price in cash, believing the acquisition demonstrates its “continued commitment to cloud-enabled and AI-powered solutions.” 
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Trump’s former FDA commissioner joins board of UnitedHealth

Scott Gottlieb, MD, will take on the new position “effective immediately.” UnitedHealth Group did not say what, if any, steering committee the former FDA lead will sit on. 

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UnitedHealthcare UHC UnitedHealth
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Trump’s former FDA commissioner joins board of UnitedHealth

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UnitedHealthcare UHC UnitedHealth
Scott Gottlieb, MD, will take on the new position “effective immediately.” UnitedHealth Group did not say what, if any, steering committee the former FDA lead will sit on. 
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