Heart failure is a chronic condition that affects more than 64 million people worldwide, and nearly 7 million in the U.S. alone. Managing heart failure is a complex challenge, often requiring frequent hospital visits to monitor symptoms and adjust treatments. As the U.S. population ages, the prevalence of heart failure is expected to rise by 24% by 2030, increasing the burden on patients and healthcare systems alike. Traditional care models often react to acute episodes rather than focusing on proactive, continuous management.
Astellas Pharma’s DIGITIVA™ offers an innovative solution to this problem. DIGITIVA is a non-invasive digital health platform designed to empower heart failure patients to take control of their condition from the comfort of home. The system combines the CORE 500™ Digital Stethoscope, a smartphone app, and a clinical review team to provide patients and physicians with real-time data on heart failure biomarkers. This allows for timely interventions before symptoms worsen, potentially preventing serious health events and reducing hospitalizations.
By integrating educational content, AI-driven insights, and a direct connection between patients and their care teams, DIGITIVA transforms heart failure management into a more proactive, personalized process. The platform provides both patients and physicians with the tools needed to monitor and manage heart failure more effectively, bridging the gap between home and clinical care.
The solution has been classified as a Class I Software as a Medical Device (SaMD), exempting it from 510(k) premarket submission.
Article written by Astellas Pharma
18/09/2024
Source:
Medi imaging
https://www.prnewswire.com/news-releases/astellas-announces-fda-listing-of-digitiva-for-the-management-of-heart-failure-302252127.html