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.

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.

After years of implanting left atrial appendage occlusion (LAAO) devices in atrial fibrillation (AFib) patients, an interventional cardiologist with the University of Chicago Medical Center (UChicago Medicine) has developed a new device that could be a more affordable alternative to Boston Scientific’s Watchman and Abbott’s Amplatzer Amulet LAA Occluder.

Cardiologist develops new heart device that uses gel to reduce stroke risk in AFib patients

After years of implanting and studying LAAO devices, an interventional cardiologist with the University of Chicago has designed a new alternative that could reduce the risk of bleeding and save health systems money.

dollar money graph increase finance

Medtronic reports rising sales for cardiovascular devices—PFA tech leads the way

Medtronic's third quarter included a boom in PFA sales and a significant investment in Anteris Technologies. CEO Geoff Martha said the company hopes to make an even bigger impact in the structural heart space as time goes on.