Astellas Pharma has announced that DIGITIVA, its non-invasive digital health solution for heart failure management, has been officially listed with the U.S. Food and Drug Administration (FDA) as a Class I Software as a Medical Device, exempt from the 510(k) premarket submission process. This marks Astellas' first digital health offering in the U.S., designed to assist heart failure patients by enabling them to take an active role in their health management. DIGITIVA integrates three key components: the CORE 500 Digital Stethoscope by Eko Health, a smartphone app tailored for heart failure patients, and a clinical review team that analyzes patient data to notify physicians about potential interventions.
The DIGITIVA platform is aimed at improving clinical outcomes by facilitating disease monitoring from home and providing real-time, AI-driven insights to both patients and healthcare providers. With heart failure affecting over 6.9 million people in the U.S. alone, the demand for innovative management solutions is significant. Astellas, a global pharmaceutical company operating in more than 70 countries, aims to leverage technology to address unmet medical needs while enhancing the patient experience. By bridging the gap between home and clinical care, DIGITIVA exemplifies Astellas' commitment to transforming healthcare delivery through cutting-edge digital solutions.
