Pulse Biosciences Pulls FDA 510(k) Application
Pulse Biosciences withdrew its FDA 510(k) application for the PulseTX nano-pulse stimulation platform.
The device uses short-duration electrical pulses directed at solid tumors to induce immunogenic cell death. The process exposes the tumor cell antigens to the immune system, which triggers an adaptive immune response.
The company pulled the application after failing to deliver requested additional information to the FDA by a Sept. 10 deadline. Pulse said it will resubmit the application.