Astellas Announces FDA Listing Of DIGITIVA For Heart Failure Management

(RTTNews) - Astellas Pharma Inc. (ALPMY, ALPMY) announced that DIGITIVA, a non-invasive digital health solution for heart failure management, has been listed with the U.S. Food and Drug Administration. DIGITIVA is classified as a Class I Software as a Medical Device (SaMD) and is exempt from 510(k) premarket submission.

The company stated that DIGITIVA is designed to place patients impacted by heart failure at the center of their care, allowing them to take a more active role in managing their health while working in partnership with their care team.

DIGITIVA is comprised of three components: the CORE 500 Digital Stethoscope developed by Eko Health Inc., a smartphone app designed for heart failure patients and built on the Welldoc, Inc. platform, bolstered by educational content from the American Heart Association, and a dedicated clinical review team.

The DIGITIVA clinical review team triages patient data, including previously elusive biomarkers specific to heart failure, and notifies the patient's treating physician when certain signals are present that may indicate the patient would benefit from intervention, with the goal of impacting clinical outcomes such as acute decompensation events and re-hospitalizations.

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