Nuwellis Receives FDA Clearance For An Additional Dual Lumen Extended Length Peripheral Catheter; Aquadex System Is Cleared By FDA For Use In Adults And Pediatric Patients Weighing 20 Kg (44 Lbs.) Or More
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Nuwellis, Inc. (NASDAQ:NUWE) has received FDA clearance for a new 12 cm dual lumen extended length catheter (dELC) for its Aquadex ultrafiltration system. This catheter provides additional venous access for treating patients with fluid overload in ICU and stepdown units. The new catheter offers the same features as the existing 16 cm version but is shorter, eliminating the need for trimming. The Aquadex system, which includes real-time hematocrit monitoring, is approved for use in adults and pediatric patients over 20 kg.
January 04, 2024 | 8:12 pm
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Nuwellis has received FDA clearance for a new 12 cm catheter for its Aquadex ultrafiltration system, which is used to treat patients with fluid overload. This approval could enhance the system's usability and market reach.
FDA clearance is a significant positive development for Nuwellis, likely to increase investor confidence and potentially lead to increased adoption of the Aquadex system in hospitals. The clearance of the new catheter could improve the system's functionality and appeal to healthcare providers, which may translate into higher sales and positive stock price movement in the short term.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100