FIRE1 is a connected medical device solutions company headquartered in Dublin, Ireland, developing the Norm™ heart failure management system. Norm™ enables physician-directed self-management by measuring fluid volume more directly and providing patients with actionable data to manage heart failure. The system is designed to reduce burdens on healthcare staff, keep patients healthier at home, and prevent frequent hospitalizations. FIRE1 completed a $120 million financing to accelerate development and will use the funds to complete a pivotal clinical trial of the Norm™ system. The company has received FDA Breakthrough Device Designation and was accepted into the FDA’s Total Product Lifecycle Advisory Program (TAP). FIRE1 collaborates with researchers, clinicians, patients, and payors and announced board additions tied to the financing. FIRE1 is a connected medical device solutions company developing a remote monitoring solution intended to improve outcomes for people with heart failure. Headquartered in Dublin, Ireland, the company says its mission is to help millions of heart failure patients regain their normal lives. The team works closely with world-leading researchers, clinicians, patients and payors to reduce the burden of chronic disease. FIRE1 recently closed an oversubscribed $25 million financing to accelerate development of its novel home monitoring solution. Management positions the product as a way to reduce hospitalizations and improve care for the large heart-failure population. FIRE1 develops a novel remote monitoring solution aimed at improving outcomes for people with heart failure. The company is led by an experienced medical devices team and works closely with researchers, clinicians, patients and payors. The financing announced will provide capital to further advance its heart-failure remote monitoring product and accelerate development. FIRE1 positions its solution as a means to manage patients at home and reduce hospitalizations and associated costs. The company is headquartered in Dublin and is the 15th medical device company from The Foundry. Management emphasizes collaboration with leading clinicians to support adoption and clinical validation. FIRE1 develops a novel remote monitoring device for medical applications. The Dublin-based company raised $7.5m in a Series B financing. Leadership includes Conor Hanley (President and CEO), John Britton (VP of Commercial Operations), and Fiachra Sweeney (Senior Director of Engineering). In conjunction with the round, The Foundry's Managing Director Mark Deem was appointed Chairman of the Board. FIRE1 is the 15th medical-device company formed by The Foundry, a Menlo Park, California incubator founded in 1998 that creates new medical device companies and works with outside clinicians and inventors. The Foundry has formed over fifteen companies, including Ardian, Concentric Medical, Evalve and Twelve, several of which were later acquired by major medical firms. FIRE1 was launched by The Foundry to develop novel therapeutic devices and is based in Dublin, Ireland. The company plans to use its Series A funding to develop and commercialize solutions addressing certain unmet medical needs. Specific market plans and financing terms were not disclosed in the announcement. The Foundry expanded FIRE1's board to include representatives from investors and partners, and Mark Deem is serving as chief executive. FIRE1 is described as The Foundry's first company created in Ireland and benefits from collaboration with strategic partners in the medical device industry. The announcement frames the partnership as aligning with Covidien's strategy to bring clinically relevant and cost-effective new treatment options to market.

Total raised

$202M

Funding rounds

5

Latest round

Equity

Latest activity

Jan 2025