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…