Clinical

This channel newsfeed includes clinical content on treating patients or the clinical implications in a variety of cardiac subspecialties and disease states. The channel includes news on cardiac surgery, interventional cardiology, heart failure, electrophysiology, hypertension, structural heart disease, use of pharmaceuticals, and COVID-19.

FDA announces new recall of Medtronic surgical devices over safety concerns
The agency warned that any unused devices should be removed from the market and returned to the manufacturer.
FDA sees promise in new AI model for heart attack detection
Powerful Medical's advanced algorithm was designed to detect STEMI and STEMI-equivalent patterns in a patient’s ECG results.
Heart transplants at VA medical center shut down after patient deaths
Safety incidents extend the halt at Richmond VA Medical Center into its 19th month, as the United Network for Organ Sharing launches its own investigation following an internal probe by Veterans Affairs.
CMS approves Medicare coverage for transcatheter tricuspid valve replacement
CMS will cover TTVR for the treatment of symptomatic tricuspid regurgitation on a national level. The agency first proposed such a policy in December, taking time to consider public comments before finalizing its decision.
Safety update: FDA announces Class I recall due to atherectomy devices breaking during use
The FDA shared a warning about these safety issues in February, but said it was still reviewing the evidence. The agency is now saying the devices “may cause serious injury or death” if used without following the updated instructions for use.

Biosense Webster, part of Johnson & Johnson MedTech, shared updated data on its Varipulse pulsed field ablation (PFA) system at AF Symposium 2024 in Boston,

Johnson & Johnson resumes PFA rollout after stopping to review safety concerns

Johnson & Johnson MedTech has resumed the U.S. rollout of its Varipulse PFA system, sharing new warnings to help physicians.

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LAAO or DOAC? Mayo Clinic AI helps guide treatment of AFib patients

It can be challenging to know which AFib patients are the best candidates for LAAO. A new algorithm out of Mayo Clinic aims to address that problem.

FDA announces new recall of Johnson & Johnson heart pumps over safety concerns

No devices need to be returned at this time. However, the FDA warned, using these heart pumps without reviewing the updated instructions could result in "serious injury or death.”

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Report: Johnson & Johnson wants to sell its stroke business for more than $1B

Johnson & Johnson has reportedly had early discussions with potential buyers about its Cerenovus division of stroke products.

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Novartis to acquire drugmaker behind new heart therapy for up to $3.1B

The FDA has already shown great interest in the drug, which is designed to help AFib patients reduce their stroke and systemic embolism risks.

Cancer patient in pain for months discovers surgical sponge in neck, lawsuit claims

Frank Kryzak has filed a lawsuit against Northwestern Medicine McHenry Hospital after an exploratory surgery allegedly left him in a mysterious state of agony for four months.

AI brings cardiology, neurology teams together to boost care for stroke patients

A new post-stroke care pathway from Viz.ai and Medtronic is associated with significant benefits, including higher patient and clinician satisfaction.

The U.S. Food and Drug Administration (FDA) has shared a new warning about ongoing safety issues with atherectomy devices sold and distributed by Bard Peripheral Vascular, an Arizona-based subsidiary of Becton, Dickinson and Company (BD). The warning includes multiple models of Bard Peripheral Vascular’s Rotarex Atherectomy System, which is designed to target high-risk plaques and blood clots in the peripheral arteries by rotating at a high speed.

FDA warns that atherectomy devices are breaking during use—30 serious injuries, 4 deaths reported

More than 100 incidents have been reported so far. The FDA is still evaluating this issue, but the agency wanted to raise awareness as quickly as possible.

Around the web

Cardiovascular Business

ACC urges RFK Jr. to make Medicare reform a priority, warns against mass layoffs

The American College of Cardiology has sent a letter to HHS Secretary Robert F. Kennedy Jr. that outlines some of the organization’s central priorities and concerns.

Radiology Business

FDA announces recall of Medtronic interventional radiology devices after 17 injuries, 4 deaths

One product is being pulled from the market, and the other is receiving updated instructions for use.

AI in Healthcare

What federal regulators can learn from the states about AI oversight

If the Trump administration continues taking a laissez-faire stance toward AI—including AI used in healthcare—why not let the states go it alone on regulating the technology?

Clinical

FDA announces new recall of Medtronic surgical devices over safety concerns

FDA sees promise in new AI model for heart attack detection

Heart transplants at VA medical center shut down after patient deaths

CMS approves Medicare coverage for transcatheter tricuspid valve replacement

Safety update: FDA announces Class I recall due to atherectomy devices breaking during use

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