Pulse biosciences provides FDA 510(k) filing update for CellFX System
Category: #healthcare  By Akshay Kedari  Date: 2020-02-15
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Pulse biosciences provides FDA 510(k) filing update for CellFX System

Pulse Biosciences, Inc., an innovative bioelectric medicine company committed to improving the lives of patients, has reportedly announced an update on its U.S. FDA ( Food and Drug Administration) submission for the CellFX System. Earlier, the company filed a 510(k) application to the FDA to obtain approval on commercializing its CellFX System.

Reportedly, the company has recently received the NSE (Not Substantially Equivalent ) letter from the agency indicating that, according to data provided, Pulse has not shown that the CellFX System is significantly equivalent to the predicate device. The company will continue to work with the FDA for the 510(k)-submission clearance and is ready to provide additional required clinical data.

Darrin Uecker, CEO and President, Pulse Biosciences, said that their firm is confident in the CellFX System and its efficacy and safety profile in aesthetic dermatology. The company would work with the agency to get approval for the CellFX system in dermatology.

Uecker added that Pulse will continue to create additional data with the support of leading dermatologists that the company has been collaborating with prior studies.

Robert Duggan, the Chairman of the Board of Directors, said that the BODs have authorized the company to take necessary steps to engage in rights offering to raise a further US$ 30million in net proceeds.

If the company gets approval on CellFX System, then it will become the first commercial product to harness the unique advantages of its proprietary NPS (Nano-Pulse Stimulation) technology for treating several applications for which the best possible solution remains unfulfilled.

NPS technology offers nano-second pulses of the electrical energy to non-thermally clear cells whilst saving nearby non-cellular tissues. CellFX System is a multi-application platform that delivers consumer value based on the utilization revenue model across an enlarging spectrum of clinical applications.

Source Credit - http://investors.pulsebiosciences.com/news-releases/news-release-details/pulse-biosciences-provides-update-fda-510k-submission-cellfx

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Akshay Kedari    

Akshay Kedari

Akshay holds a Bachelor’s degree in computer engineering. Despite having a penchant for software development and the like, Akshay took to writing as a career owing to his passion for the field. Presently, Akshay writes articles for itresearchbrief.com and a few oth...

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