NUWE News & Events

Nuwellis announced the completion of a recent pre-submission meeting with the FDA regarding the proposed label expansion of the Aquadex SmartFlow System to support pediatric patients weighing 5 kg and above. The currently cleared indication is for patients weighing 20 kg and above. The company said, "The pre-submission meeting provided constructive feedback on the Company's proposed regulatory strategy, including a pathway toward a 510(k) submission supported by targeted bench testing, toxicological assessments, and pediatric clinical evidence. The feedback provides important clarity as Nuwellis advances its regulatory and clinical plans in this high-need patient population. The Company anticipates submitting to the FDA by the end of 2026."

Nuwellis announced that the U.S. Patent and Trademark Office, or USPTO, has issued a notice of allowance for a new patent covering its novel dual lumen midline catheter technology designed for use in ultrafiltration therapies. This catheter incorporates design elements to optimize blood flow dynamics during therapy. The technology includes separate withdrawal and infusion lumens with pressure-balancing features that help maintain stable flow and reduce complications associated with fluid removal procedures.

Nuwellis announces the return of three former team members: Liby Cielo, Principal Account Manager; Meredith Stein, Senior Clinical Education Specialist; and Scott Campbell, Area Vice President, Sales. "The addition of these returning team members reflects Nuwellis' continued focus on strengthening its commercial and clinical capabilities and supporting hospitals treating patients with complex cardiorenal conditions," the company said.