Astellas’ New Heart Failure Treatment DIGITIVA™ Gets FDA Listing

Astellas Pharma Inc., led by President and CEO Naoki Okamura, has revealed that DIGITIVA™, a groundbreaking non-invasive digital health tool for managing heart failure, has received listing from the U.S. Food and Drug Administration (FDA). As a Class I Software as a Medical Device (SaMD), DIGITIVA is not required to undergo the 510(k) premarket submission process*. This marks Astellas' inaugural entry into the U.S. digital health market.

DIGITIVA aims to empower patients with heart failure by placing them at the heart of their own care. It enables individuals to take an active role in managing their health while collaborating closely with their care team. The DIGITIVA system includes three key elements: the CORE 500™ Digital Stethoscope from Eko Health Inc., a smartphone app for heart failure patients built on the Welldoc, Inc. platform and enriched with educational content from the American Heart Association, and a specialized clinical review team. 

This team analyzes patient data, including previously hard-to-detect heart failure biomarkers, and alerts the treating physician when specific signals suggest the need for intervention. The ultimate aim is to improve clinical outcomes, such as reducing acute decompensation events and hospital readmissions. Heart failure is a major global health challenge, impacting over 64 million individuals worldwide. In the United States alone, an estimated 6.9 million people were affected in 2020, with projections indicating a 24% rise to nearly 8.5 million by 2030. This increase is attributed to the ageing population and overall demographic growth.

Richard Cassidy, Head of Rx+ Business Accelerator, Astellas, said in a statement, “We believe DIGITIVA has the potential to help patients and their physicians better manage heart failure by providing patients with a new option that facilitates disease monitoring from home, enabling physician intervention, as needed. DIGITIVA was developed within the Astellas Rx+ Business Accelerator and exemplifies our commitment to pioneering digital health technologies that provide personalized and accessible care with the goal of improving health outcomes. This achievement marks a significant milestone for Astellas as we integrate innovative technology with tailored patient support.”

Connor Landgraf, Co-founder and CEO, Eko Health, further added, “The realization of DIGITIVA is a remarkable stride toward transforming the landscape of tools available to manage heart health by bridging the gap between home and clinic care. By joining forces with Astellas, we have seamlessly integrated our cutting-edge CORE 500 Digital Stethoscope and AI technology with a highly engaging DTx app with the goal of moving us toward a future where heart failure is actively managed rather than treated reactively.”

Kevin McRaith, President and CEO, Welldoc, also mentioned, “DIGITIVA embodies the potential of digital health by equipping patients with the information, support and resources they need to manage their heart health from the comfort of home. By integrating Welldoc’s platform, DIGITIVA provides patients with AI-driven real-time and personalized feedback that can help promote positive lifestyle changes, while also offering physicians data-driven insights for tailored clinical decision-making.”