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News You Need to Know Today
FDA takes on unauthorized BP devices | Registry helps hospitals expand outpatient services | A key approval for Medtronic
Thursday, September 18, 2025
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Today's News and Trends

FDA highlights risks of evaluating blood pressure with unauthorized medical devices

The agency emphasized that many over-the-counter technologies marketed for this purpose have not been properly evaluated. 

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blood pressure hypertension cuff
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FDA highlights risks of evaluating blood pressure with unauthorized medical devices

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blood pressure hypertension cuff
The agency emphasized that many over-the-counter technologies marketed for this purpose have not been properly evaluated. 
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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

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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.
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 >

World’s most populous country gains access to Medtronic’s newest TAVR valve

Medtronic developed the self-expanding Evolut FX+ TAVR system with improved coronary access in mind. The FDA-approved device has now officially launched in India. 

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Medtronic Evolut FX+ TAVR
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World’s most populous country gains access to Medtronic’s newest TAVR valve

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Medtronic Evolut FX+ TAVR
Medtronic developed the self-expanding Evolut FX+ TAVR system with improved coronary access in mind. The FDA-approved device has now officially launched in India. 
READ MORE >

Featured Articles

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 >

In Case You Missed It

Update: FDA announces new Class I recalls due to safety issue with Medtronic catheters

More than 100,000 surgical devices are included in these recalls, and there may be "limited product availability" in the months ahead. The FDA first warned the public about this issue in August. 

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the words "FDA recall" on a board
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Update: FDA announces new Class I recalls due to safety issue with Medtronic catheters

Share on Twitter Share on Facebook Share on Linkedin
the words "FDA recall" on a board
More than 100,000 surgical devices are included in these recalls, and there may be "limited product availability" in the months ahead. The FDA first warned the public about this issue in August. 
READ MORE >

3D echo guidance seeing increasing use in congenital heart surgery

Pei-Ni Jone, MD, FASE, director, echocardiography laboratory, Lurie Children’s Hospital Heart Center, member of the American Society of Echocardiography (ASE) Board, explains how 3D echo is being used to better plan, guide and follow up in congenital cardiac surgery.

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Pei-Ni Jone, MD, FASE, director, echocardiography laboratory, Lurie Children’s Hospital Heart Center, professor of pediatric cardiology, Northwestern University Feinberg School of Medicine, member of the American Society of Echocardiography (ASE) Board, and the chair of the ASE Pediatric and Congenital Heart Disease Council Steering Committee, explains how 3D echo is being used to better plan, guide and followup in congenital cardiac surgery.
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3D echo guidance seeing increasing use in congenital heart surgery

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Pei-Ni Jone, MD, FASE, director, echocardiography laboratory, Lurie Children’s Hospital Heart Center, professor of pediatric cardiology, Northwestern University Feinberg School of Medicine, member of the American Society of Echocardiography (ASE) Board, and the chair of the ASE Pediatric and Congenital Heart Disease Council Steering Committee, explains how 3D echo is being used to better plan, guide and followup in congenital cardiac surgery.
Pei-Ni Jone, MD, FASE, director, echocardiography laboratory, Lurie Children’s Hospital Heart Center, member of the American Society of Echocardiography (ASE) Board, explains how 3D echo is being used to better plan, guide and follow up in congenital cardiac surgery.
READ MORE >

Philips launches smart telemetry platform for cardiac monitoring

Care teams can face alarm and cognitive overload, with an average of 350 alarms going off per patient per day. But Philips' new telemetry platform streamlines alarm management, delivers data-driven insights and automates clinical tasks—with operational simplicity and networking options.

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Philips introduced a new cardiac monitoring telemetry platform designed to help address critical challenges in healthcare, including staff shortages and alarm management. A key component of the solution is the next-generation Telemetry Monitor 5500 is an integrated central monitoring unit solution that integrates the telemetry device platform.
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Philips launches smart telemetry platform for cardiac monitoring

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Philips introduced a new cardiac monitoring telemetry platform designed to help address critical challenges in healthcare, including staff shortages and alarm management. A key component of the solution is the next-generation Telemetry Monitor 5500 is an integrated central monitoring unit solution that integrates the telemetry device platform.
Care teams can face alarm and cognitive overload, with an average of 350 alarms going off per patient per day. But Philips' new telemetry platform streamlines alarm management, delivers data-driven insights and automates clinical tasks—with operational simplicity and networking options.
READ MORE >

In Other News

Healthcare AI today: Another angle on AI regulation, move fast but don’t break things, WISeR in the real world, more

Getting healthcare AI to fulfill its destiny—can we call it that now?—will require ‘scenario-based’ consideration of every use case.

READ MORE >
healthcare AI regulation
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Healthcare AI today: Another angle on AI regulation, move fast but don’t break things, WISeR in the real world, more

Share on Twitter Share on Facebook Share on Linkedin
healthcare AI regulation
Getting healthcare AI to fulfill its destiny—can we call it that now?—will require ‘scenario-based’ consideration of every use case.
READ MORE >

Lit review identifies a ‘glaring gap’ involving older Americans and healthcare AI

Conventional wisdom has it that older adults willingly lag behind younger subpopulations when it comes to reaping the benefits of emerging healthcare technologies, including AI. 

READ MORE >
older adults technology
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Lit review identifies a ‘glaring gap’ involving older Americans and healthcare AI

Share on Twitter Share on Facebook Share on Linkedin
older adults technology
Conventional wisdom has it that older adults willingly lag behind younger subpopulations when it comes to reaping the benefits of emerging healthcare technologies, including AI. 
READ MORE >

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