Pulse Biosciences Provides Update on FDA 510(k) Submission for the CellFX System in Dermatology
Pulse Biosciences, Inc (PLSE)
Last pulse biosciences, inc earnings: 11/7 03:42 pm
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Source: Business Wire
Schedules Business Update Call on February 18, 2020 at 2:00pm PT HAYWARD, Calif.--(BUSINESS WIRE)--Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company, today announced an update on its U.S. Food and Drug Administration (FDA) submission for the CellFX System. Previously, the Company submitted a 510(k) to FDA seeking clearance to commercialize its CellFX System. On February 13, 2020, the Company received a Not Substantially Equivalent (NSE) letter from FDA indicating that, based on the data provided, the Company has not demonstrated that the CellFX System is substantially equivalent to the predicate device. The Company will continue to work with FDA in pursuit of a clearance via a new 510(k) submission and is prepared to provide additional clinical data as required.“We remain highly confident in the CellFX System and its safety and efficacy profile in aesthetic dermatology. We look forward to continuing to work with FDA to obtain a clearance for the CellFX sy
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