Pulse Biosciences Gets FDA's Breakthrough Status for Surgery System
By Dean Seal
Pulse Biosciences said federal regulators have granted their breakthrough device designation for its cardiac surgery system for the ablation of cardiac tissue during atrial fibrillation.
The Miami-based company said the Food and Drug Administration's special designation would help it seek premarket approval for the system in the treatment of atrial fibrillation.
"We look forward to aligning with the FDA on a pivotal clinical trial design in the near-term and towards initiating our planned first-in-human cases in the Netherlands soon," Chief Executive Burke Barrett said.
Breakthrough device designation is granted to devices that may provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions for which no approved alternative exists.
Write to Dean Seal at dean.seal@wsj.com
(END) Dow Jones Newswires
July 08, 2024 08:49 ET (12:49 GMT)
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