regulatory
confidence high
sentiment positive
materiality 0.55
Nuwellis gets FDA 510(k) clearance for new catheter size
Nuwellis, Inc.
- FDA 510(k) clearance received for new size of Nuwellis' Dual Lumen Extended Length Catheter (dELC) on August 21, 2025.
- Clearance allows Nuwellis to market the new size catheter in the United States.
- No specific dimensions, commercial launch date, or revenue impact disclosed.
item 8.01