Cardiosense Receives FDA De Novo Classification for Novel Cardiac Technology Designed to Improve Care for Patients with Heart Failure
This is the first noninvasive, AI-powered tool that provides a critical heart pressure reading for patients with heart failure
CHICAGO–(BUSINESS WIRE)–Cardiosense, a healthcare technology company focused on heart failure care, today announced that the U.S. Food & Drug Administration (FDA) has granted De Novo classification for its PCWP Analysis Software™, a first-in-class technology to estimate a key indicator of heart health noninvasively. With this authorization, Cardiosense has a clear path forward in supporting clinicians who manage heart failure by providing critical data to improve therapy and avoid prolonged hospitalizations.
