FDA awards Breakthrough Device Designation to Fire1’s Norm™ system

DUBLIN – Strictly embargoed to 08.00 hours GMT/Dublin time Jan. 7, 2025

FIRE1, a leading connected medical device solutions company, today announced the successful completion of a $120 million financing round to accelerate the company’s mission to transform the lives of millions of people living with heart failure.

FIRE1’s Norm™ heart failure management system offers a groundbreaking 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 funding will enable the company to complete a pivotal clinical trial of the Norm™ system.

The round was led by Polaris Partners and Elevage Medical Technologies, joined by new investors Sands Capital and Longitude Capital, and existing investors Andera Partners, Gilde Healthcare, Gimv, the Ireland Strategic Investment Fund, Lightstone Ventures, Medtronic, NEA (New Enterprise Associates), Novo Holdings, and Seventure Partners.