Pulse Biosciences discloses NSE letter from FDA on CellFX system

Pulse Biosciences (NASDAQ:PLSE) -25.2% after-hours following the disclosure of a “Not Substantially Equivalent” letter from the Food and Drug Administration related to its CellFX system.

Pulse says the FDA letter indicated that the company had not demonstrated that the CellFX System is substantially equivalent to the predicate device.

“We look forward to continuing to work with FDA to obtain a clearance for the CellFX system in dermatology [and] will continue to generate additional clinical data in support of that effort,” the company says.

https://seekingalpha.com/news/3542079-pulse-biosciences-discloses-nse-letter-from-fda-on-cellfx-system