Pulse Biosciences fails to get FDA’s expanded approval for CellFX System

Pulse Biosciences fails to get FDA’s expanded approval for CellFX System

The US Food and Drug Administration (FDA) has rejected an application of Pulse Biosciences is seeking expansion to the current labeling of CellFX System to include its use for the treatment of sebaceous hyperplasia. The bioelectric medicine company said that the FDA issued an additional information (AI) letter stating that it needs more clinical evidence […]