Nuwellis, Inc., a medical device company, develops, manufactures, and commercializes medical devices used in ultrafiltration therapy. The company provides Aquadex FlexFlow and Aquadex SmartFlow systems, which are used to treat patients suffering from fluid overload due to heart failure, as well as Aquadex SmartFlow system for temporary use in adult and pediatric patients. The company was formerly known as CHF Solutions, Inc. and changed its name to Nuwellis, Inc. in April 2021. Nuwellis, Inc. was founded in 1999 and is headquartered in Eden Prairie, Minnesota.
Nuwellis to Convene Pediatric Medical & Nursing Advisory Board to Advance Development of Vivian™ Pediatric CRRT System
Nuwellis will convene a Medical & Nursing Advisory Board on November 18-19, 2026 to support development of Vivian, its next-generation pediatric CRRT platform designed for children as small as 2.5kg.
About a dozen pediatric providers, nurses, and clinical advisors from 11 nationally recognized U.S. pediatric institutions will provide hands-on evaluation of the latest Vivian System, the company's first dedicated Vivian advisory board in several years.
Separately, Nuwellis is seeking to expand the Aquadex SmartFlow indication to pediatric patients weighing 5 kilograms or more, down from the current 20-kilogram minimum labeled weight.
The advisory board is a development-stage milestone with no regulatory approval or commercial outcome announced; execution risk remains given the company's disclosed funding needs.