The US Food and Drug Administration (FDA) has listed Astellas Pharma’s non-invasive digital health solution, DIGITIVA, designed for the management of heart failure.
Classified as a Class I Software as a Medical Device (SaMD), DIGITIVA is not required to undergo the 510(k) premarket submission process.
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It aims to empower patients with heart failure to take a more active role in their care by placing them at the centre of their health management.
The three components of DIGITIVA include the CORE 500 Digital Stethoscope developed by Eko Health, a patient-focused smartphone app built on the Welldoc platform, and educational content provided by the American Heart Association.
The solution also comprises a dedicated clinical review team to support patient care.
This comprehensive approach is designed to facilitate a collaborative relationship between patients and their healthcare providers.
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By GlobalDataAstellas Rx+ Business Accelerator head Richard Cassidy said: “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.
“DIGITIVA was developed within the Astellas Rx+ Business Accelerator and exemplifies our commitment to pioneering digital health technologies that provide personalised and accessible care with the goal of improving health outcomes.”
The clinical review team will monitor patient data, including specific biomarkers for heart failure.
They alert the patient’s physician when intervention may be beneficial, aiming to improve clinical outcomes such as reducing acute decompensation events and re-hospitalisations.
Astellas Pharma and Eko Health entered a licence and supply agreement in July 2023. This agreement covers the provision of Eko Health’s CORE 500 digital stethoscope and its AI-driven software suite for detecting cardiovascular diseases, further solidifying the foundation of the DIGITIVA system.
