Fire1 System Receives FDA Breakthrough Device Designation

Jan. 7, 2025 — FIRE1 recently announced it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) and has been accepted into the FDA’s Total Product Lifecycle Advisory Program (TAP). 

FIRE1’s Norm heart failure management system offers a unique approach for patients to manage heart failure. By enabling patients to engage in physician directed self-management, Norm reduces the burden on healthcare staff, making it easier to keep patients healthier and at home.

The company also announced Ellie McGuire, Partner at Polaris Partners, and Michael Wasserman, Partner and COO at Elevage Medical Technologies have joined its Board of Directors.

“FIRE1 has developed a groundbreaking solution to one of healthcare’s most pressing challenges: providing scalable ways to manage the disease of chronically ill patients and prevent the need for frequent hospitalizations,” said McGuire. “The Norm heart failure self-management system is a first-of-its-kind innovation that empowers patients to take greater control of their health. We believe this represents a paradigm shift in chronic disease management.”

Wasserman added, “FIRE1’s unique approach to heart failure—a more direct measure of volume instead of relying on proxies—has generated significant excitement in the clinical community. This differentiated approach positions FIRE1 to unlock substantial market opportunities, and we are proud to support the company on this journey.”

FIRE1 also announced the successful completion of a $120 million financing round to accelerate the company’s mission to help people living with heart failure. The funding will enable the company to complete a pivotal clinical trial of the Norm system.

“From the beginning, our team has been driven by two core goals: creating a better way to manage heart failure by monitoring fluid volume more directly, and empowering patients with actionable data to improve their lives” said Conor Hanley, CEO and president of FIRE1. 

For more information, visit www.fire1foundry.com.