Aquadex — NDA/BLA submission
Q4 2026
Q4 2026 FDA 510k submission for Pediatric indication expansion to 5kg (from 20kg)Source filing
NUWELLIS INC · Data as of 2026-09-08
Q4 2026
Q4 2026 FDA 510k submission for Pediatric indication expansion to 5kg (from 20kg)Source filing
2Q 2028
IDE submission with the the FDA expected in 2Q 2028Source filing
Q3 2026
Q3 2026 Publication of ULTRA-Peds dataSource filing