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.

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.

artificial intelligence AI heart cardiology

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.

Surgeons transplanting a pig heart into a human patient.

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.

Edwards Lifesciences Corporation has shared new one-year data on the safety and effectiveness of its Evoque transcatheter tricuspid valve replacement (TTVR) system among patients with tricuspid regurgitation (TR)

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.

Bard Peripheral Vascular Rotarex Atherectomy System recall

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.

Clinical support tool for pediatric autism earns $27M from private equity

Motivity is receiving an injection of cash from Five Elms Capital, a software investment firm. The companies said the funds will be used to hire staff and improve products.

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.

The rapid rise of artificial intelligence (AI) has helped cardiologists, radiologists, nurses and other healthcare providers embrace precision medicine in a way that ensures more heart patients are receiving personalized care.

The revolution is here: AI’s growing role in cardiovascular imaging, interventional cardiology

AI has already made a massive impact on healthcare, especially in the fields of cardiology and radiology. With the FDA clearing more and more algorithms, this trend is only expected to grow as time goes on.

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?