Pulse Biosciences Receives the US FDA IDE Approval to Initiate Study for nsPFA System in Paroxysmal Atrial Fibrillation (PAF)

Shots: The US FDA has granted IDE approval to initiate the NANOPULSE-AF study of Pulse's nsPFA Cardiac Catheter System for the treatment of PAF The study will assess the primary safety and efficacy of the nsPFA Cardiac Catheter System in ~145 pts for the treatment of drug-resistant symptomatic PAF across 30 sites, incl. 3 outside…

ByRidhi RastogiDecember 19, 2025

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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 US The EU feasibility study of nsPFA Cardiac Clamp began in Aug 2024 with over 40 pts across 3 sites The Netherlands,…

ByRidhi RastogiSeptember 9, 2025

Pulse Biosciences Receives the US FDA IDE Approval to Initiate Study for nsPFA System in Paroxysmal Atrial Fibrillation (PAF)

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

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