The company also reached a major FDA milestone with breakthrough device designation. The agency also accepted its technology into its Total Product Lifecycle Advisory Program (TAP). TAP provides early and frequent strategic engagement from the FDA, patients, providers and payers. It facilitates rapid development and widespread access to medical devices.

Dublin, Ireland–based Fire1 develops the Norm heart failure management system that enables patients to engage in physician-directed self-management. Norm aims to reduce the burden on healthcare staff and make it easier to keep patients healthier and at home.

Fire1 said the funding — led by Polaris Partners and Elevage Medical Technologies — enables the completion of a pivotal clinical trial. New investors Sands Capital and Longitude Capital participated as well. Existing investors Andera Partners, Gilde Healthcare, Gimv, the Ireland Strategic Investment Fund, Lightstone Ventures, Medtronic, NEA (New Enterprise Associates), Novo Holdings, and Seventure Partners, all joined in.