Nuwellis Seeks FDA Clearance for Aquadex Use in Children Weighing 5 kg and Above

Bitget2026/11/05 13:32

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Nuwellis submitted a 510(k) application seeking FDA clearance for Aquadex SmartFlow use in pediatric patients weighing at least 5 kg.
The system is currently cleared for patients weighing at least 20 kg.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Nuwellis Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202611050830PRIMZONEFULLFEED9870933) on November 05, 2026, and is solely responsible for the information contained therein.

Disclaimer: The content of this article solely reflects the author's opinion and does not represent the platform in any capacity. This article is not intended to serve as a reference for making investment decisions.

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Nuwellis Seeks FDA Clearance for Aquadex Use in Children Weighing 5 kg and Above

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