Nuwellis submits 510(k) to FDA to expand Aquadex SmartFlow indication to pediatric patients

Nuwellis submitted a 510(k) premarket notification to the FDA seeking to expand the indication of its Aquadex SmartFlow System to include pediatric patients weighing 5 kg and above, extending its current clearance which is limited to patients weighing 20 kg and above.

Detected & updated continuously · Source: Nebula