Vektor Medical Secures the European CE Mark Approval for AI-Powered vMap System to Advance Arrhythmia Care

Shots:Vektor Medical has received the European CE Mark approval for vMap System for non-invasive arrhythmia mappingvMap System converts 12-lead ECG data into 3D arrhythmia source maps within a minute to help identify arrhythmia drivers & guide treatment for atrial fibrillation & ventricular tachycardiaThe system also integrates with lab workflows to deliver rapid, non-invasive,…

ByRidhi RastogiOctober 8, 2025

NEWS

Pulse Biosciences Receives FDA IDE Approval for nsPFA Cardiac Surgery System to Treat Atrial Fibrillation

Shots:Pulse Biosciences has received the US FDA IDE approval to initiate its NANOCLAMP AF study evaluating nsPFA system in ~136 pts with atrial fibrillation (AF) across 20 sites, incl. 2 outside the USThe EU feasibility study of nsPFA Cardiac Clamp began in Aug 2024 with over 40 pts across 3 sites The Netherlands,…

ByRidhi RastogiSeptember 9, 2025

NEWS

CoreMap Reports the US FDA’s IDE Approval for CoreMap’s EP Map-Guided AF Ablation Study

Shots:CoreMap received the US FDA’s IDE approval of CoreMap EP (Endocardial Electrophysiology) to extend the 3-phase INvENI clinical study into the US in pts with Atrial Fibrillation (AF) and long-standing persistent AFThe P-I study assessed acute safety of CoreMap EP in 14 pts while P-II study showed acute safety & effectiveness in 15 pts. The…

ByRidhi RastogiMay 30, 2025

NEWS

Abbott Secures European CE Mark for Volt PFA System to Treat Atrial Fibrillation

Shots:Abbott has received European CE Mark for its Volt PFA System to treat pts with atrial fibrillation; commercialization has begun, with further expansion in EU markets expected by H2’25Approval was based on CE Mark study in the EU & Australia, showing that the Volt achieved pulmonary vein isolation (PVI) in 99.1% veins with…

ByRidhi RastogiMarch 28, 2025

NEWS

Johnson & Johnson’s Reports the CE Mark Approval for Dual Energy Thermocool Smarttouch SF Catheter for Cardiac Arrhythmias

Shots:The CE mark of Thermocool Smarttouch SF Catheter for cardiac arrhythmias was based on SmartfIRE trial in European patients with refractory PAF that depicted 100% acute success rate & first-pass isolation achievement in 96.8% of veins (published in Apr 2024). The Trupulse Generator hardware compatibility is anticipated in H1’25 The company has concluded…

ByRidhi RastogiJanuary 13, 2025

VIEWPOINTS

Ruud Dobber Shares Insights from RWE Data from the REVEAL-CKD Presented at the ERA-EDTA’23

Shots:Ruud talked about the key findings from the new RWE data at ERA-EDTA'23 which demonstrated the staggeringly low rate of diagnosis in chronic kidney disease (CKD)He then discussed the risk factors of CKD and the urgent need to act on the growing global burden of CKD and how this disease is impacting the…

BySenior EditorSeptember 25, 2023

VIEWPOINTS

Dr. Christopher Piorkowski Shares His Views on the US FDA Approval of TactiFlex Ablation Catheter to Treat Abnormal Heart Rhythm

Shots:Christopher started by highlighting the working of the TactiFlex Ablation Catheter and how it can be used for the treatment of patients with Atrial FibrillationHe also talked about the study design and the key findings from the TactiFlex AF IDE trial. He later gave a comparative view of the TactiFlex catheter vs. conventional…

BySenior EditorSeptember 11, 2023

Vektor Medical Secures the European CE Mark Approval for AI-Powered vMap System to Advance Arrhythmia Care

Pulse Biosciences Receives FDA IDE Approval for nsPFA Cardiac Surgery System to Treat Atrial Fibrillation

CoreMap Reports the US FDA’s IDE Approval for CoreMap’s EP Map-Guided AF Ablation Study

Abbott Secures European CE Mark for Volt PFA System to Treat Atrial Fibrillation

Johnson & Johnson’s Reports the CE Mark Approval for Dual Energy Thermocool Smarttouch SF Catheter for Cardiac Arrhythmias

Ruud Dobber Shares Insights from RWE Data from the REVEAL-CKD Presented at the ERA-EDTA’23

Dr. Christopher Piorkowski Shares His Views on the US FDA Approval of TactiFlex Ablation Catheter to Treat Abnormal Heart Rhythm

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