Healthcare IT Today January 20, 2025
Healthcare IT News

FDA Awards Breakthrough Device Designation to Fire1’s Norm System

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...

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Topics: FDA, Govt Agencies, Medical Devices
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