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- He concluded, “We are pleased with how quickly the FDA cleared these new energy settings based on the data we provided, requiring 53 of the allotted 90-day review period, to determine that the expanded settings are safe and effective for use with the CellFX System.
- “Pulse Biosciences is dedicated to providing dermatologists a superior solution for the treatment of benign lesions and to advancing the CellFX System and its capabilities.
- Food and Drug Administration (FDA) 510(k) clearance of expanded energy settings for use with the family of CellFX System treatments tips in dermatology.
Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company commercializing the CellFX® System powered by Nano-Pulse Stimulation™ (NPS™) technology, today announced receipt of U.S. Food and Drug Administration (FDA) 510(k) clearance of expanded energy settings for use with the family of CellFX System treatments tips in dermatology.
“Pulse Biosciences is dedicated to providing dermatologists a superior solution for the treatment of benign lesions and to advancing the CellFX System and its capabilities. Clinicians in the U.S. are now able to access broader treatment settings to provide more customized energy delivery specific to individual lesions,” said Darrin Uecker, President and Chief Executive Officer of Pulse Biosciences.”
He concluded, “We are pleased with how quickly the FDA cleared these new energy settings based on the data we provided, requiring 53 of the allotted 90-day review period, to determine that the expanded settings are safe and effective for use with the CellFX System. We appreciate the ongoing collaboration with FDA as we continue to expand the clinical applications for the CellFX System.”
