Abbott Launches Next-Generation Of EnSite Cardiac Mapping System

The EnSite XP three-dimensional mapping earned a CE mark and regulatory approval in Australia.

Abstract heart made of electric lighting effect
• Source: shutterstock.com

Abbott is launching the EnSite X cardiac electrophysiology mapping system in Europe and Australia after it received a CE mark and Australian Therapeutic Goods Administration approval, the company announced on 2 November.

EnSite X is a new cardiac mapping system for cardiac ablation built on the company’s existing EnSite mapping system with...

More from Approvals

More from Policy & Regulation

Deaths And Serious Injuries Linked To A Pair Of Heart Device Recalls

 

Two recent recalls from the US FDA involve three deaths linked to an issue with an Abiomed heart pump — as well as three serious injuries related to angiographic catheters from Cook Medical.

‘Be Quick, But Don’t Hurry’: Dexcom CEO Talks CGM Market Success

 
• By 

Dexcom’s CEO Kevin Sayer discusses this fall’s planned launch of the 15-day G7 CGM, downplays Abbott’s dual-sensor while focusing on development of multi-analyte G8, making OTC Stelo app more “consumerish” for Europeans, and more.

June 2025: A Bumper Month For New EU Medtech Documents And Initiatives

 

The rate at which new documents to support the implementation of EU medtech regulations are issued has slowed of late; but June bucked the trend, with a flurry of activity.