Surgical devices included in multiple Class I recalls | FDA approves finerenone for heart failure | AI-enhanced echo impresses

Edwards Lifesciences has recalled more than 61,000 medical devices due to the risk of a small piece of wire becoming exposed. No patient injuries have been reported at this time.

Finerenone, sold by Bayer under the brand name Kerendia, is now approved in the United States for the treatment of HFmrEF and HFpEF. The drug has already been used for years to treat patients with chronic kidney disease and type 2 diabetes.

The first FDA-cleared AI model of its kind was found to be an accurate screening tool for cardiac amyloidosis.

The Varipulse PFA platform originally gained FDA approval in 2024. According to Johnson & Johnson MedTech, this update was put in place to help the technology provide better patient outcomes going forward.

This proposal, if finalized, would dramatically increase patient access to renal denervation. Both Recor Medical and Medtronic have shared their excitement over the news.

The new guidelines detail the use of echocardiography to evaluate patients for a variety of conditions.

The use of advanced AI software to assess CCTA images continues to gain more momentum.

The new warnings, first proposed to Pfizer and Moderna in April, are now officially required by the FDA. They provide additional information about the potential risks of myocarditis and/or pericarditis associated with these vaccines.

All over the United States, countless research projects designed to improve outcomes have lost funding or been shut down. Even screening efforts targeting patients in impoverished communities have been impacted by these policies.

Researchers explored more than 52 years of data, highlighting several key trends in the Journal of the American Heart Association.

After issuing a 50% tariff on copper imports this week, President Donald Trump said a massive levy on drugs could be announced “very soon.” The details are currently unknown. 

Experts are hopeful the software can bring more objectivity to the diagnostic process by giving providers visual evidence of alterations in brain activity.