08:09 AM EDT, 09/08/2025 (MT Newswires) -- Pulse Biosciences ( PLSE ) said Monday the US Food and Drug Administration approved its investigational device exemption to begin a study of its nsPFA Cardiac Surgery System for rapid and irregular heartbeats.

The trial will enroll up to 136 patients in 20 sites, including two outside the US, the company said.

The device was designed to create continuous ablations during cardiac surgery while reducing the risk of collateral tissue damage compared with thermal methods, the company said.

The company also said early feasibility testing in Europe has treated more than 40 patients with reported rapid ablation times and consistent results.