Nuwellis Receives FDA 510(k) Clearance for New Dual Lumen Extended Length Catheter - Candlesense
NUWE Regulatory

Nuwellis Receives FDA 510(k) Clearance for New Dual Lumen Extended Length Catheter

MINNEAPOLIS, Aug. 21, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on fluid management, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for a new size of its Dual Lumen Extended Length Catheter (dELC).

Related Questions

How will the FDA 510(k) clearance affect Nuwellis' revenue forecasts and earnings guidance? What is the expected market adoption rate for the new dual lumen extended length catheter relative to competitors' offerings? Will this clearance accelerate the company's product pipeline timeline and lead to further regulatory submissions or strategic partnerships?
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