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.

Q&A: What cardiologists know and don’t know about pulsed field ablation
Peter Weiss, MD, a veteran electrophysiologist, sat down with Cardiovascular Business to discuss the ongoing rise of pulsed field ablation. While he's impressed with the technology, he says many questions remain about its long-term value.
FDA details Class I recalls for more than 1 million pacemakers—software update required
The FDA has finalized new Class I recalls related to ongoing safety concerns with Boston Scientific’s Accolade family of pacemakers. A software update is now available to help address the issue, and an additional update is already in the works.
FDA approves Zoll's newest defibrillator-monitor
The device, based on years of user feedback, is now cleared for use in both EMS and hospital settings.
AI-powered cardiac mapping system gains an important approval
The vMap System from San Diego-based Vektor Medical turns 12-lead ECGs into 3D maps of the heart. It has already been cleared by the FDA.
Next-generation Watchman enters trial in 2026 as LAAO volume grows
The next-generation Watchman device is designed to better seal off complex LAA anatomy in a variety of LAA shapes and sizes.

Q&A: What cardiologists know and don’t know about pulsed field ablation

Peter Weiss, MD, a veteran electrophysiologist, sat down with Cardiovascular Business to discuss the ongoing rise of pulsed field ablation. While he's impressed with the technology, he says many questions remain about its long-term value.

FDA details Class I recalls for more than 1 million pacemakers—software update required

The FDA has finalized new Class I recalls related to ongoing safety concerns with Boston Scientific’s Accolade family of pacemakers. A software update is now available to help address the issue, and an additional update is already in the works.

The U.S. Food and Drug Administration (FDA) granted pre-market approval (PMA) clearance for Zoll Zenix defibrillator-monitor for EMS and hospital use. It incorporates new technology and features based on years of user feedback.

FDA approves Zoll's newest defibrillator-monitor

The device, based on years of user feedback, is now cleared for use in both EMS and hospital settings.

The Vektor Medical vMap system takes standard 12-lead ECGs and converts them into detailed electro anatomical maps for us in catheter ablation procedures.

AI-powered cardiac mapping system gains an important approval

The vMap System from San Diego-based Vektor Medical turns 12-lead ECGs into 3D maps of the heart. It has already been cleared by the FDA.

The next generation Watchman device is designed to better seal off complex LAA anatomy to prevent strokes in atrial fibrillation patients. It uses an optimized architecture to fill gaps and adapt to the unique characteristics of each patient's appendage, which come in a wide variety of shapes and sizes.

Next-generation Watchman enters trial in 2026 as LAAO volume grows

The next-generation Watchman device is designed to better seal off complex LAA anatomy in a variety of LAA shapes and sizes.

Sentiar CommandEP mixed reality system virtual screens augmented reality

Virtual screens could make augmented reality more useful during cardiac ablation

It's still early, but a new feature could provide significant value when electrophysiologists use augmented reality during ablation procedures.

Abbott has recalled its TactiFlex Ablation Catheter, Sensor Enabled, because of reports that the tip can separate.

Abbott warns EP labs the tip can detach from its TactiFlex ablation catheters

Improper removal of the catheter from the packaging can result in tip damage. Most damaged tips were detected prior to being used, but three tips did separate inside patients.

All medical device products in Europe need to obtain the Conformité Européenne mark (European Conformity, or CE mark) regulatory approval. This is based on minimal safety requirements and is needed to be sold in the EU.

Cardiologists lead charge for medical device approvals in Europe to be more rigorous

There is a belief among some clinicians that it is too easy for companies to gain CE mark approval for their medical devices. However, a new proposal from the European Society of Cardiology and other groups could help change that.