PartnershipJun 10, 2026, 08:31 AM
Nuwellis Expands Aquadex Collaboration with SC Healthcare System
AI Summary
Nuwellis, Inc. announced an expanded collaboration with a major South Carolina healthcare system to integrate its Aquadex SmartFlow devices into a children's hospital. The healthcare provider also upgraded to the latest Aquadex devices at two existing facilities. This move validates Nuwellis' ultrafiltration system as a clinically important solution for fluid overload, reinforcing its leadership in the pediatric category. Additionally, Nuwellis recently completed a pre-submission meeting with the FDA to propose expanding the Aquadex SmartFlow System's label to include pediatric patients weighing 5 kg and above, with anticipated submission by year-end 2026.
Key Highlights
- Nuwellis expanded collaboration with a major South Carolina healthcare system.
- Aquadex SmartFlow devices will be integrated into one of the healthcare system's children's hospitals.
- The provider upgraded to the latest Aquadex devices at two existing locations.
- Nuwellis completed a pre-submission meeting with the FDA for label expansion to pediatric patients weighing 5 kg and above.
- The company anticipates submitting to the FDA by the end of 2026 for this label expansion.
- Aquadex system is currently designed for adult and pediatric patients weighing 20 kg and above.
Price Impact
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