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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.
| Electrocardiography

Massachusetts-based Zoll has received U.S. Food and Drug Administration (FDA) approval for its Zenix defibrillator-monitor for EMS and hospital use. The device includes new…

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

San Diego-based Vektor Medical has gained CE mark approval for the vMap System, which uses artificial intelligence (AI) to turn 12-lead electrocardiograms (ECGs) into…

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.

Boston Scientific announced at its Investor Day event Sept. 30 it plans to launch its fourth-generation Watchman left atrial appendage closure (LAAC) device, which will…

Sentiar CommandEP mixed reality system virtual screens augmented reality
| Heart Rhythm

The use of augmented reality (AR) during cardiac ablation procedures may be improved by adding “virtual screens” that clinicians can customize as they see fit. That was the primary takeaway of a new analysis published in the Journal of…

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| Policy & Regulations

A safety issue with certain Boston Scientific defibrillation leads has resulted in a series of new Class I recalls, according to the U.S. Food and Drug Administration (FDA). Unlike some recalls, these do not…

money business cash flow dollar
| Electrophysiology

Boston Scientific has agreed to acquire Elutia’s drug-eluting envelope business for $88 million. The cash transaction is expected to close in late 2025.

Elutia is the Maryland-based medtech company behind…

| Echocardiography

Evaluating left ventricular diastolic function (LVDF) with echocardiography can help identify individuals at an increased risk of developing atrial fibrillation (AFib), according to new findings presented at the American…

Newsweek ranked the 50 best heart hospitals in the world
| Electrophysiology

In July, the Centers for Medicare and Medicaid Services (CMS) proposed adding procedure codes for cardiac ablations to the Ambulatory Surgical Center (ASC) Covered Procedures List as part of the…

The U.S. Food and Drug Administration (FDA) has granted pre-market approval (PMA) for the Globe Pulsed Field Ablation (PFA) System, and 510(k) clearance for both the Globe introducer sheath and the Globe Pulsed Field System mapping software from Kardium Inc. This add another competitor in the growing U.S. PFA market to treat atrial fibrillation (AFib).
| Electrophysiology

The U.S. Food and Drug Administration (FDA) has granted pre-market approval (PMA) for the Globe Pulsed Field Ablation (PFA) System, along with 510(k) clearance for both the Globe introducer sheath and the Globe Pulsed Field System mapping…

Philips introduced a new cardiac monitoring telemetry platform designed to help address critical challenges in healthcare, including staff shortages and alarm management. A key component of the solution is the next-generation Telemetry Monitor 5500 is an integrated central monitoring unit solution that integrates the telemetry device platform.
| Remote Monitoring

Philips introduced a new cardiac monitoring telemetry platform designed to address critical challenges in healthcare, including staff shortages and alarm management. A key component of the solution is the next-generation…

Stereotaxis MAGIC SWEEP electrophysiology catheter
| Electrophysiology

There has been a movement in electrophysiology (EP) labs to adopt high-density mapping catheters that allow more detailed information on the electrical activity in…

Biosense Webster, part of Johnson & Johnson MedTech, shared updated data on its Varipulse pulsed field ablation (PFA) system at AF Symposium 2024 in Boston,
| Electrophysiology

Pulsed field ablation (PFA) with Johnson & Johnson MedTech’s Varipulse platform is safe and effective, according to new real-world data presented at ESC Congress 2025…

Farapulse Boston Scientific Pulsed Field Ablation PFA fda approval
| Heart Rhythm

Phrenic nerve injury (PNI) may still be a significant concern following pulsed field ablation (PFA) for atrial fibrillation (AFib), according to a new single-center study published in Heart Rhythm.[1]

“PNI is a known complication…

Reprocessed Supreme Fixed Electrophysiology Catheter
| Electrophysiology

Medline ReNewal, Medline’s medical device reprocessing program, has announced that certain electrophysiology catheters should be removed from the market and returned to the manufacturer due to a risk that they may contain “small residual…

Watchman TruSteer Access System
| Interventional Cardiology

Boston Scientific’s Watchman device is associated with a heightened risk of air embolism events if the implant procedure is performed without positive pressure-controlled ventilation,…

U.S. FDA Sign
| Policy & Regulations

The U.S. Food and Drug Administration (FDA) is sharing additional details about a safety issue with certain Boston Scientific defibrillation leads. 

According to the agency, some of the company’s…

| Cardiac Imaging

Coronary computed tomography angiography (CCTA) is more effective than transesophageal echocardiography (TEE) when it comes to detecting residual leaks following…

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| Heart Rhythm

Early rhythm control (ERC) is still an effective treatment for atrial fibrillation (AFib) when patients also present with obesity or diabetes, according to a new analysis published in JAMA Cardiology.[1]

The international…

cardiologists heart doctors heart research heart data
| TAVR

Giving colchicine to patients before transcatheter aortic valve replacement (TAVR) may reduce the risk of certain conduction disturbances, according to new research…