CHF Solutions submits 510(k) application for Use of Aquadex FlexFlow® System with Pediatric Patients
CHF SOLUTIONS INC (CHFS)
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Source: GlobeNewswire
EDEN PRAIRIE, Minn., Oct. 01, 2019 (GLOBE NEWSWIRE) -- CHF Solutions, Inc. (Nasdaq:CHFS) today announced that it has submitted an application to the FDA requesting for 510(k) clearance of the Aquadex FlexFlow system to include pediatric patients who weigh 20kg or more. Subject to FDA review, the company expects clearance for this pediatric population by the end of the year. “We are excited to have achieved this significant milestone in our corporate strategy to make the Aquadex FlexFlow technology available to pediatric patients,” said John L. Erb, chairman and CEO of CHF Solutions. “Following FDA clearance, we look forward to expanding use for these most vulnerable patients, who have limited alternative solutions.” “We are pleased with CHF Solutions’ commitment to taking the regulatory steps to support our efforts in delivering this therapy to pediatric patients,” said Dr. Stuart L. Goldstein, Director of the Center for Acute Care Nephrology at Cincinnati Children's Hospital Medi
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