Nuwellis Plans 510(k) Submission to Expand Aquadex to 5 kg Pediatric Patients
NUWE•Nuwellis completed an FDA pre-submission 510(k) meeting for Aquadex SmartFlow, targeting label expansion to treat pediatric patients weighing from 5 kg to the current 20 kg threshold. FDA feedback outlined required bench tests, toxicology assessments and pediatric clinical evidence, with a 510(k) submission expected by end-2026.
1. FDA Pre-Submission Meeting Completed
Nuwellis completed a pre-submission 510(k) meeting with the FDA to discuss expanding the Aquadex SmartFlow System label to pediatric patients weighing as little as 5 kg, below the current 20 kg limit.
2. Regulatory Feedback Outlines Submission Path
During the meeting the FDA provided constructive feedback on the proposed regulatory strategy, including requirements for targeted bench testing, toxicological assessments and pediatric clinical evidence, and indicated a 510(k) submission by end-2026 would be appropriate.
3. Pediatric Market Expansion Potential
Expanding the indication to the 5–20 kg pediatric population addresses a significant unmet need in low-weight patients requiring controlled ultrafiltration, potentially unlocking a high-growth segment for Nuwellis and broadening its cardiorenal therapy portfolio.
