FDA clears nano-pulse stimulation tech for treating hyperplasia from Pulse Biosciences

The CellFX system. [Image from Pulse Biosciences]Pulse Biosciences (Nasdaq:PLSE) announced today that the FDA granted 510(k) clearance for its CellFx system with expanded indication.

The new indication covers the treatment of sebaceous hyperplasia in patients with Fitzpatrick skin types I-III. Clearance followed positive clinical data from an investigational device exemption (IDE) study of the system.

CellFX uses Pulse Biosciences’ proprietary nano-pulse stimulation (NPS) technology. NPS technology delivers nanosecond pulses of electrical energy to non-thermally clear cells while sparing adjacent non-cellular tissue.

Hayward, California-based Pulse Biosciences said CellFX represents the first commercial product to use NPS technology to treat a variety of conditions. The company is pursuing development in cardiology, oncology, gastroenterology, and other medical specialties.

Pulse Biosciences also received FDA clearance for two additional treatm…

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  • September 26, 2022
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Pulse Biosciences names chief strategy officer

Pulse Biosciences (NSDQ:PLSE) announced today that it appointed Mitchell E. Levinson to its newly created chief strategy officer role.

Hayward, Calif.-based Pulse Biosciences said in a news release that Levinson’s new role, which begins effective immediately, will be held in addition to his position as a member of the company’s board of directors.

Pulse Biosciences develops the CellFX system, powered by nano-pulse stimulation, for the delivery of nanosecond pulses of electrical energy designed to clear cells while sparing adjacent non-cellular tissue.

“As a board member and medical device industry veteran with a track record of successfully bringing new technologies and products to market across a variety of medical specialties, Mitch’s insights have benefitted Pulse Biosciences for over five years,” Pulse Biosciences president & CEO Darrin Uecker said in the release. “We are thrilled to add him to the executive leadership team at this cr…

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  • August 20, 2021
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