Astellas Announces FDA Listing of DIGITIVA™ for the Management of Heart Failure

Product Overview - DIGITIVA™ is a non-invasive digital health solution for heart failure management, classified as a Class I Software as a Medical Device (SaMD) and exempt from FDA's 510(k) premarket submission [1] - The solution integrates three components: CORE 500™ Digital Stethoscope, a smartphone app for heart failure patients, and educational content from the American Heart Association, supported by a clinical review team [2] - DIGITIVA aims to improve clinical outcomes by enabling at-home disease monitoring and facilitating timely physician intervention [2] Market and Industry Context - Heart failure affects over 64 million people globally, with 6.9 million cases in the U.S. (2020 estimate), projected to increase by 24% to nearly 8.5 million by 2030 due to population aging and growth [3] - The solution represents a significant milestone for Astellas as its first digital health offering in the U.S., developed within the Rx+ Business Accelerator to integrate innovative technology with patient support [3] Technology and Partnerships - DIGITIVA leverages Eko Health's CORE 500 Digital Stethoscope and AI technology, combined with Welldoc's AI-driven platform for real-time, personalized feedback and data-driven clinical insights [4][5] - The collaboration with Eko Health and Welldoc aims to bridge the gap between home and clinic care, enabling proactive management of heart failure [4][5] Company Background - Astellas Pharma operates in over 70 countries, focusing on creating new drugs for diseases with high unmet medical needs and developing Rx+ healthcare solutions by combining expertise with cutting-edge technology [8] - Eko Health, with over $165 million in funding, provides FDA-cleared digital stethoscopes and AI-powered analysis used by over 500,000 healthcare professionals worldwide [9] - Welldoc, a leader in digital health, offers AI-powered coaching for cardiometabolic conditions and has achieved 11 FDA 510(k) clearances and 45 patents for its advanced AI technology [10][11] Financial Impact - Astellas has already incorporated the financial impact of DIGITIVA's FDA listing into its fiscal year 2025 forecast [5]