Medtronic is recalling more than 700 OmniaSecure defibrillation leads, urging customers to quarantine and return them. The FDA has ruled this is a Class II recall. No adverse events have been reported.

Abbott's Amplatzer Paraclose PVL Occluder is the first heart device of its kind approved by the FDA to treat paravalvular leak. The agency made its decision after reviewing data from 200 patients who had undergone aortic or mitral valve replacement surgery.

Medtronic identified an issue with its CareLink SmartSync device manager providing inaccurate longevity estimates for certain leadless pacemakers. Customers can download a software update to resolve the issue going forward.

The new device from Chicago-based Parasol Med Tech uses gel to seal the left atrial appendage. It leaves no metal hardware behind.

Surgical bailout during TAVR is growing increasingly rare as time goes on. Does that mean it is time to rethink certain coverage policies? A new study and two separate editorials examined this topic in great detail.

The Center for Healthcare Quality and Payment Reform believes many physicians participating in the new Ambulatory Specialty Model could end up experiencing a pay cut. In addition, it could drive some specialists to stop treating heart failure patients altogether.

The procedure, believed to be the first of its kind, was performed at the 2026 European Association for Cardio-Thoracic Surgery annual meeting in Barcelona, Spain.

The FDA previously warned that certain Impella heart pump controllers may need hardware, firmware and/or software updates. The agency has now categorized the issue as a Class I recall. The devices should be removed from where they are used or sold until they can be serviced, but they can still be used if necessary to ensure patients receive care.

Andrew Einstein, MD, PhD, spoke to Cardiovascular Business about the potential benefits and limitations of using coronary CT angiography as a screening modality.

Heartflow filed the lawsuit after Elucid received FDA clearance for its new AI-enabled FFR-CT software. Elucid, meanwhile, is standing behind its technology and plans on responding through the appropriate legal channels.