Expertise and commitment of FDA reviewers remain in place, but the agency’s ability to communicate openly with industry has become a significant concern.
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.
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.
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.
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.
Eko Health's Core 300 stethoscope offers noise cancellation, amplification and a real-time display of the patient's heart data. Clinicians can also use the same device for traditional analog listening.
SCAI surveyed its members to find out what they thought about potential changes to current TAVR policies. The responses to that survey helped influence the group's official stance.
Traditionally, the interventional cardiologist first visualizes the coronary anatomy in detail when contrast is injected in the catheterization laboratory. For many patients, however, that anatomy has already been captured, often in considerable detail, by coronary CT angiography (CCTA) performed earlier in the clinical pathway. This article considers how this dataset can be used to plan the procedure, an approach referred to as CT-guided PCI.
