Astellas Pharma Inc. has announced that its digital health solution, DIGITIVA™, has been officially listed by the U.S. Food and Drug Administration (FDA) for managing heart failure. This innovative product is classified as a Class I Software as a Medical Device (SaMD) and is exempt from the 510(k) premarket submission process.
DIGITIVA marks Astellas’ first digital health offering in the United States.
DIGITIVA aims to empower patients with heart failure by placing them at the center of their care. It encourages patients to take an active role in managing their health while collaborating closely with their healthcare teams. The system consists of three main components: the CORE 500™ Digital Stethoscope from Eko Health Inc., a smartphone app tailored for heart failure patients developed on the Welldoc, Inc.
platform, and educational resources from the American Heart Association. Additionally, a dedicated clinical review team monitors patient data, including important biomarkers related to heart failure, and alerts physicians when intervention may be necessary. This proactive approach aims to improve clinical outcomes by reducing acute decompensation events and hospital readmissions.
Richard Cassidy, Head of Astellas’ Rx+ Business Accelerator, emphasized that DIGITIVA has the potential to enhance heart failure management for both patients and doctors. He noted that it provides a new option for monitoring health from home, enabling timely physician intervention when required. Cassidy highlighted that DIGITIVA represents Astellas’ commitment to advancing digital health technologies that offer personalized and accessible care.
Heart failure is a significant global health concern, affecting over 64 million people worldwide. In the United States alone, approximately 6.9 million people were estimated to have heart failure in 2020, with projections indicating an increase to nearly 8.5 million by 2030 due to an aging population.
Connor Landgraf, Co-founder and CEO of Eko Health, remarked that the launch of DIGITIVA is a significant advancement in managing heart health by connecting home care with clinical settings. The collaboration with Astellas has integrated Eko’s CORE 500 Digital Stethoscope and AI technology into an engaging digital therapy app, paving the way for more proactive heart failure management.
Kevin McRaith, President and CEO of Welldoc, stated that DIGITIVA exemplifies the power of digital health by providing patients with essential information and resources for managing their heart health from home. The integration of Welldoc’s platform allows for real-time AI-driven feedback, promoting positive lifestyle changes while offering physicians valuable data for informed clinical decisions.
Astellas has already incorporated the impact of the FDA listing into its financial forecasts for the current fiscal year ending March 31, 2025.
Note: The FDA categorizes medical devices into three classes based on their safety and effectiveness, with Class I devices being considered low-risk.