Nuwellis receives FDA 510k clearance for new dELC

Nuwellis (NUWE) announced it has received U.S. Food and Drug Administration 510(k) clearance for a new size of its Dual Lumen Extended Length Catheter, dELC. This clearance supports Nuwellis’ multi-year plan to build a fluid management platform-combining therapy delivery, dedicated venous access, and practical implementation support-so hospitals and clinics can standardize how they identify patients, begin ultrafiltration therapy earlier, and sustain programs from the ICU to step-down and hospital-based outpatient settings. The company’s strategy centers on three growth drivers: critical care, cardiac surgery recovery, and hospital-based outpatient heart failure programs.