Electrophysiology

The cardiac subspecialty of electrophysiology (EP) diagnoses and treats arrhythmias. This includes use of pacemakers to treat bradycardia, implantable cardioverter defibrillators (ICD) for tachycardia, heart failure and patients at risk of sudden cardiac arrest, and cardiac ablation treatments to treat heart rhythm disorders.

Xiaodong Zhang, MD, PhD,

Cardiologist makes history with first commercial implant of new pacing lead for LBBAP

The first FDA-approved pacing lead specifically developed for LBBAP is now being implanted throughout the United States. 

OmniaSecure defibrillation lead approved by FDA for placement in LBB area

FDA approves smallest defibrillation lead of its kind for LBBA placement

The OmniaSecure defibrillation lead from Medtronic is already approved for placement in the right ventricle. This latest approval covers the left bundle branch area, opening the door for conduction system pacing and other advanced techniques.

Ligence Heart is a recently FDA cleared AI that fully automates analyses, measurements and reporting for transthoracic echo.

Cardiology now has more than 200 FDA-cleared AI algorithms

Cardiology is No. 2 behind radiology when it comes to FDA-cleared AI algorithms. Neurology, meanwhile, is a distant No. 3. 

FDA issues recall of imaging systems

FDA shares details about reprocessed catheter recall

Back in February, the FDA expanded a recall of several reprocessed EP and ultrasound catheters due to a risk of contamination. The agency is now sharing additional information with the public.

Farapulse Boston Scientific Pulsed Field Ablation PFA fda approval

Boston Scientific’s Farapulse PFA system receives expanded approval

The technology first gained CE mark approval for the treatment of paroxysmal AFib in 2021, when PFA was still brand new. Now, thanks to positive results from the ADVANTAGE AF clinical trial, it is approved for persistent AFib as well. 

simulation of the conduction pathway relative to various cardiac structures.

FDA clears AI-powered platform that personalizes care during TAVR, cardiac pacing procedures

The newly cleared CARA System from Cara Medical was designed to help clinicians before and during a variety of cardiac procedures. It provides a personalized 3D map of the patient's cardiac conduction system and then overlays that map onto live fluoroscopic images.

Biotronik has secured U.S. Food and Drug Administration (FDA) approval for its Solia CSP S pacing lead for left bundle branch area pacing (LBBAP).

FDA approves new Biotronik pacing lead for LBBAP

The next-generation device includes a stylet-driven lead and a fixed helix. It was designed and developed specifically with LBBAP in mind. 

Conformal Medical CLAAS

Gore completes acquisition of medtech company behind next-gen heart device

Gore has officially acquired Conformal Medical, the company known for an investigational LAAO device that uses a proprietary foam implant. The transaction was first announced in January.