Sept. 18, 2024 – Astellas Pharma Inc. recently announced that Digitiva, a non-invasive digital health solution for heart failure management, has been listed with the U.S. Food and Drug Administration (FDA).
Digitiva is classified as a Class I Software as a Medical Device (SaMD) and is exempt from 510(k) premarket submission*. Digitiva is the first digital health offering from Astellas in the U.S.
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, supported 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.
“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," said Richard Cassidy, Head of Rx+ Business Accelerator, Astellas "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.”
“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,” said Connor Landgraf, Co-founder and CEO, Eko Health.
“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,” Kevin McRaith, President and CEO, Welldoc
To learn more, please visit the Astellas Pharma website.
*FDA classifies medical devices into three different classes based on the device's safety and effectiveness. Class I includes those devices with the lowest risk, and Class III includes those devices with the greatest risk such as life-supporting or life-sustaining devices. Most Class I and some Class II devices are exempt from FDA's 510(k) premarket review. Virtually all Class III devices require premarket approval (or a PMA) that must be supported by valid scientific evidence (often well-controlled clinical studies) to demonstrate the device is safe and effective for its intended use.
January 27, 2026 
