Heart Rhythm

Hearts should have normal rhythm to their beats, but when these beats are out of synch, it causes inefficient pumping of blood. Irregular heart arrhythmias occur when the electrical signals that coordinate the heart's beats do not work properly. This can cause beats that are too fast (tachycardia), or too slow (bradycardia). Tachycardias include atrial fibrillation (AFib), supraventricular tachycardia, ventricular fibrillation, and ventricular tachycardia (VT). Bradycardias include sick sinus syndrome and conduction block. Electrophysiology arrhythmia treatments include medications, life style changes, and the EP lab interventions of catheter ablation, and implantable pacemakers or defibrillators.

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.
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.
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.
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.
Death after PCI seen in just 0.5% of patients—heart attack, cardiac arrest most common causes
The new analysis included data from more than 22,000 PCI patients treated at one of two high-volume U.S. facilities. Infection was the most common noncardiac cause of death.

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.

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for a 12-lead electrocardiogram (ECG) synthesis software for home assessment of arrhythmias. This clearance follows HeartBeam’s successful appeal of a prior "not substantially equivalent (NSE) determination.

FDA clears 12-lead, cable-free home ECG monitoring system

The new technology synthesizes signals from a credit card-sized device into a 12-lead ECG representation.

Universal heart screening for all athletes? Not so fast, cardiologists warn

Mandates for universal ECG screening are gaining momentum as a way to combat the risk of SCA. However, the ACC warned, modern healthcare systems were not built to withstand such a rise in demand. These mandates will also result in higher costs and other unintended consequences.

New heart catheter for cell therapy delivery 1 step closer to FDA approval

The BioCardia delivery catheter was designed to be used by interventional cardiologists, electrophysiologists or cardiac surgeons. It includes a tiny needle that directly engages with the patient’s cardiac tissue.

Reprocessed EP catheters recalled due to contamination risk

The FDA has announced seven Class I recalls related to this issue. Customers are urged to destroy the devices immediately instead of returning them to the manufacturer.

The HeartBeam AIMIGo device is approximately the size of a credit card and uses the company’s patented 3D vectorelectrocardiography (3D VECG) technology to capture signals from three different projections and deliver a synthesized 12-lead ECG.

ECG market keeps evolving thanks to AI, home monitoring and Epic integration

For years, the ECG market was relatively static. According to a new report, however, things are rapidly changing.

warning safety alert recall healthcare issue

Safety update: New recommendations for managing patients with high-risk defibrillation leads

HRS has shared an updated guidance on managing Boston Scientific defibrillation leads at risk of experiencing a significant malfunction. The issue, first reported in July 2025, is believed to impact approximately 350,000 leads still being used today.

Boston EP Party: Medtech companies share new electrophysiology data at AF Symposium 2026

AF Symposium 2026 in Boston included new data from some of the biggest names in electrophysiology. Johnson & Johnson MedTech, Abbott, Atraverse Medical, Field Medical, Pulse Biosciences, Argá Medtech SA and CardioFocus were just some of the medtech companies at the heart of late-breaking presentations.

Heart Rhythm

FDA shares details about reprocessed catheter recall

Boston Scientific’s Farapulse PFA system receives expanded approval

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

FDA approves new Biotronik pacing lead for LBBAP

Death after PCI seen in just 0.5% of patients—heart attack, cardiac arrest most common causes