Astellas' DIGITIVA™ Listed by FDA for Heart Failure Management

Astellas Pharma has announced FDA listing for DIGITIVA™, a non-invasive digital tool for managing heart failure. DIGITIVA, developed in collaboration with Eko Health and Welldoc, uses the CORE 500™ Digital Stethoscope and AI-based smartphone app to remotely monitor patients, improving clinical outcomes while reducing re-hospitalizations. It prioritizes home-based care, empowering patients to manage their heart health alongside clinicians.

DIGITIVA provides real-time patient data, including heart-specific biomarkers, which the dedicated clinical review team analyzes. This data allows healthcare providers to identify potential intervention needs early, ensuring timely care. Astellas sees this development as a pivotal moment in its Rx+ digital health initiative, aiming to combine technology with tailored patient support to enhance healthcare outcomes.

Heart failure affects over 64 million people worldwide, with U.S. cases projected to increase. DIGITIVA is expected to play a key role in addressing this growing health challenge.

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