Soliton Provides FDA Update and Addresses Recent Anonymous Article
Soliton, Inc. (SOLY)
Company Research
Source: PR Newswire
HOUSTON, May 17, 2019 /PRNewswire/ -- Soliton, Inc., (Nasdaq: SOLY) ("Soliton" or the "Company"), a medical device company with a novel and proprietary platform technology licensed from The University of Texas on behalf of the MD Anderson Cancer Center ("MD Anderson"), today provided an update on its application for FDA clearance and addressed a recent anonymous article published on SeekingAlpha.com."We know there is a lot of focus on whether or not, and when, Soliton can achieve FDA clearance to market its new Rapid Acoustic Pulse (RAP) technology," commented Dr. Chris Capelli, President and CEO of Soliton. "So, we would like to provide some insight regarding where we stand in this process. We submitted our request for marketing clearance, referred to as a "510(k)," in March of this year. The targeted time period for review of a 510(k) application is 90 days. This means we should be receiving feedback from the FDA before the end of this month. Importantly, we have not been notif
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