Astellas Pharma has announced the listing of DIGITIVA, its non-invasive digital health solution for heart failure management, with the US Food and Drug Administration (FDA).
The FDA listing classifies DIGITIVA as a Class 1 software-as-a-medical device (SaMD) and exempts it from 510(k) premarket submission.
DIGITIVA is designed to enhance care for patients impacted by heart failure, enabling them to more actively manage their health while working with their care team.
It contains three components, the CORE 500 Digital Stethoscope developed by Eko Health, a mobile app built on the Welldoc platform, and a dedicated clinical review team.
The smartphone app comes with educational content from the American Heart Association.
The clinical review team triages patient data, including previously elusive biomarkers specific to heart failure, and notifies the physician when the patient can benefit from intervention.
Eko Health co-founder and CEO Connor Landgraf said: “By joining forces with Astellas, we have seamlessly integrated our cutting-edge CORE 500 Digital Stethoscope and AI technology with a highly engaging DTx app with the goal of moving us toward a future where heart failure is actively managed rather than treated reactively.”
Welldoc president and CEO Kevin McRaith said: “DIGITIVA embodies the potential of digital health by equipping patients with the information, support and resources they need to manage their heart health from the comfort of home.
“By integrating Welldoc’s platform, DIGITIVA provides patients with AI-driven real-time and personalised feedback that can help promote positive lifestyle changes, while also offering physicians data-driven insights for tailored clinical decision-making.”
According to Astellas, its DIGITIVA mobile application offers a customised program for adults with an existing diagnosis of heart failure or other cardiac conditions.
DIGITIVA helps the patients promote, track, and encourage healthy choices that may reduce the risk of, or to live well with their cardiac conditions.
It creates a report that allows healthcare providers to view patient data and gain insights into the challenges that patients face between appointments.
Astellas 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.
“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.
“This achievement marks a significant milestone for Astellas as we integrate innovative technology with tailored patient support.”
