Astellas Announces FDA Listing of DIGITIVA™ for the Management of Heart Failure
Astellas Pharma Inc. (TSE: 4503) has announced the FDA listing of DIGITIVA™, a non-invasive digital health solution for heart failure management. This Class I Software as a Medical Device (SaMD) is exempt from 510(k) premarket submission and marks Astellas' first digital health offering in the U.S. DIGITIVA comprises three components: the CORE 500™ Digital Stethoscope by Eko Health Inc., a smartphone app built on Welldoc, Inc.'s platform with American Heart Association content, and a dedicated clinical review team.
DIGITIVA aims to place patients at the center of their care, allowing for at-home disease monitoring and facilitating physician intervention when needed. The solution targets the growing heart failure prevalence in the U.S., expected to reach 8.5 million by 2030. Astellas has incorporated the impact of this FDA listing into its financial forecast for the fiscal year ending March 31, 2025.
Astellas Pharma Inc. (TSE: 4503) ha annunciato l'elenco della FDA per DIGITIVA™, una soluzione digitale non invasiva per la gestione dell'insufficienza cardiaca. Questo software di Classe I come Dispositivo Medico (SaMD) è esente dalla presentazione pre-market 510(k) e segna la prima offerta di salute digitale di Astellas negli Stati Uniti. DIGITIVA è composta da tre componenti: il CORE 500™ Stetoscopio Digitale di Eko Health Inc., un'app per smartphone basata sulla piattaforma di Welldoc, Inc. con contenuti dell'American Heart Association, e un team di revisione clinica dedicato.
DIGITIVA mira a porre i pazienti al centro della loro cura, permettendo il monitoraggio della malattia a casa e facilitando l'intervento del medico quando necessario. La soluzione affronta la crescente prevalenza dell'insufficienza cardiaca negli Stati Uniti, che si prevede raggiungerà 8,5 milioni di casi entro il 2030. Astellas ha incorporato l'impatto di questo elenco della FDA nella sua previsione finanziaria per l'anno fiscale che si concluderà il 31 marzo 2025.
Astellas Pharma Inc. (TSE: 4503) ha anunciado la inclusión en la FDA de DIGITIVA™, una solución de salud digital no invasiva para la gestión de la insuficiencia cardíaca. Este Software como Dispositivo Médico de Clase I (SaMD) está exento de la presentación previa 510(k) y marca la primera oferta de salud digital de Astellas en los EE. UU. DIGITIVA consta de tres componentes: el CORE 500™ Estetoscopio Digital de Eko Health Inc., una aplicación para smartphone desarrollada en la plataforma de Welldoc, Inc. con contenido de la Asociación Americana del Corazón, y un equipo clínico de revisión dedicado.
DIGITIVA tiene como objetivo colocar a los pacientes en el centro de su atención, permitiendo el monitoreo de enfermedades en casa y facilitando la intervención del médico cuando sea necesario. La solución está dirigida a la creciente prevalencia de la insuficiencia cardíaca en EE. UU., que se espera alcance los 8.5 millones para 2030. Astellas ha incorporado el impacto de esta inclusión en la FDA en su pronóstico financiero para el año fiscal que termina el 31 de marzo de 2025.
Astellas Pharma Inc. (TSE: 4503)는 심부전 관리를 위한 비침습적 디지털 건강 솔루션 DIGITIVA™의 FDA 등재를 발표했습니다. 이 클래스 I 의료 기기 소프트웨어(SaMD)는 510(k) 사전 시장 제출에서 면제되며 Astellas의 미국에서 첫 번째 디지털 건강 제품을 의미합니다. DIGITIVA는 Eko Health Inc.의 CORE 500™ 디지털 청진기, 미국 심장 협회 내용을 포함한 Welldoc, Inc. 플랫폼 기반의 스마트폰 애플리케이션, 그리고 전담 임상 리뷰 팀의 세 가지 구성 요소로 이루어져 있습니다.
DIGITIVA는 환자를 치료의 중심에 두는 것을 목표로 하여, 자택에서의 질병 모니터링을 가능하게 하고 필요 시 의사의 개입을 용이하게 합니다. 이 솔루션은 2030년까지 850만 명에 이를 것으로 예상되는 미국 내 심부전 환자의 증가하는 유병율을 목표로 하고 있습니다. Astellas는 이 FDA 등재의 영향을 2025년 3월 31일로 종료되는 회계연도의 재정 예측에 반영했습니다.
Astellas Pharma Inc. (TSE: 4503) a annoncé l'inscription par la FDA de DIGITIVA™, une solution de santé numérique non invasive pour la gestion de l'insuffisance cardiaque. Ce logiciel de Classe I en tant que Dispositif Médical (SaMD) est exempt de la soumission préalable 510(k) et représente la première offre de santé numérique d'Astellas aux États-Unis. DIGITIVA se compose de trois éléments : le CORE 500™ Stéthoscope Numérique d'Eko Health Inc., une application pour smartphone développée sur la plateforme de Welldoc, Inc. avec le contenu de l'American Heart Association, et une équipe dédiée à la révision clinique.
DIGITIVA vise à placer les patients au centre de leur soin, permettant le suivi de la maladie à domicile et facilitant l'intervention du médecin si nécessaire. La solution cible la prévalence croissante de l'insuffisance cardiaque aux États-Unis, qui devrait atteindre 8,5 millions d'ici 2030. Astellas a intégré l'impact de cette inscription de la FDA dans ses prévisions financières pour l'année fiscale se terminant le 31 mars 2025.
Astellas Pharma Inc. (TSE: 4503) hat die FDA-Zulassung für DIGITIVA™, eine nicht-invasive digitale Gesundheitslösung für die Behandlung von Herzinsuffizienz, bekannt gegeben. Diese Software der Klasse I als Medizinprodukt (SaMD) ist von der 510(k) Marktprüfungspflicht befreit und markiert Astellas' erstes digitales Gesundheitsangebot in den USA. DIGITIVA besteht aus drei Komponenten: dem CORE 500™ Digitalen Stethoskop von Eko Health Inc., einer Smartphone-App, die auf der Plattform von Welldoc, Inc. mit Inhalten der American Heart Association basiert, und einem spezialisierten klinischen Überprüfungsteam.
DIGITIVA zielt darauf ab, die Patienten in den Mittelpunkt ihrer Versorgung zu stellen, indem sie eine Überwachung der Erkrankung zu Hause ermöglicht und bei Bedarf eine ärztliche Intervention erleichtert. Die Lösung richtet sich gegen die zunehmende Prävalenz von Herzinsuffizienz in den USA, die bis 2030 voraussichtlich 8,5 Millionen erreichen wird. Astellas hat die Auswirkungen dieser FDA-Zulassung in seine finanzielle Prognose für das zum 31. März 2025 endende Geschäftsjahr einbezogen.
- FDA listing of DIGITIVA™ as a Class I Software as a Medical Device (SaMD)
- DIGITIVA is exempt from 510(k) premarket submission, potentially accelerating market entry
- First digital health offering from Astellas in the U.S. market
- Targets growing heart failure market, expected to reach 8.5 million patients in the U.S. by 2030
- Collaboration with established partners: Eko Health Inc., Welldoc, Inc., and American Heart Association
- Highly competitive digital health market with numerous existing solutions
- Potential challenges in user adoption and integration with existing healthcare systems
- Dependence on patient compliance and consistent use for effectiveness
- New digital health solution for heart failure management puts patients at the center of their care by providing ability for at-home disease monitoring -
DIGITIVA is designed to place patients impacted by heart failure at the center of their care, allowing them to take a more active role in managing their health while working in partnership with their care team. DIGITIVA is comprised of three components: the CORE 500™ Digital Stethoscope developed by Eko Health Inc., a smartphone app designed for heart failure patients and built on the Welldoc, Inc. platform, bolstered by educational content from the American Heart Association, and a dedicated clinical review team. The DIGITIVA clinical review team triages patient data, including previously elusive biomarkers specific to heart failure, and notifies the patient's treating physician when certain signals are present that may indicate the patient would benefit from intervention, with the goal of impacting clinical outcomes such as acute decompensation events and re-hospitalizations.
Richard Cassidy, Head of Rx+ Business Accelerator, Astellas
"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 personalized 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."
Heart failure is a global health issue affecting more than 64 million people worldwide1. In the
Connor Landgraf, Co-founder and CEO, Eko Health
"The realization of DIGITIVA is a remarkable stride toward transforming the landscape of tools available to manage heart health by bridging the gap between home and clinic care. 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."
Kevin McRaith, President and CEO, Welldoc
"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 personalized feedback that can help promote positive lifestyle changes, while also offering physicians data-driven insights for tailored clinical decision-making."
Astellas has already reflected the impact from the FDA listing in its financial forecast of the current fiscal year ending March 31, 2025.
For additional information, the DIGITIVA™ Instructions for Use are linked here5 and the CORE 500™ Digital Stethoscope Instructions for Use are linked here6.
*FDA classifies medical devices into three different classes based on the device's safety and effectiveness. Class I includes those devices with the lowest risk, and Class III includes those devices with the greatest risk such as life-supporting or life-sustaining devices. Most Class I and some Class II devices are exempt from FDA's 510(k) premarket review. Virtually all Class III devices require premarket approval (or a PMA) that must be supported by valid scientific evidence (often well-controlled clinical studies) to demonstrate the device is safe and effective for its intended use.
About Astellas
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into VALUE for patients. For more information, please visit our website at https://www.astellas.com/en.
About Eko Health
Eko Health is a leading digital health company advancing how healthcare professionals detect and monitor heart and lung disease with its portfolio of digital stethoscopes, patient and provider software, and AI-powered analysis. Its FDA-cleared platform, used by over 500,000 healthcare professionals worldwide, allows them to detect earlier and with higher accuracy, diagnose with more confidence, manage treatment effectively, and ultimately give their patients the best care possible. Eko Health is headquartered in
About Welldoc
Welldoc®, a digital health leader revolutionizing cardiometabolic care, is integrating personalized, real-time and actionable insights into the daily lives of individuals living with cardiometabolic conditions, enabling improved health and outcomes. Welldoc's comprehensive digital health platform provides AI-powered digital coaching across pre-diabetes, diabetes, hypertension, heart failure and weight and obesity management, with integrated mental wellbeing and sleep support. Welldoc's flagship product, BlueStar®, is an FDA-cleared digital health solution that guides individuals through the complicated journey of living with diabetes by enabling them to self-manage their care while enhancing connections to their healthcare team. These capabilities are now integrated into the Welldoc platform, providing comprehensive and flexible support across conditions. The company partners with health plans, health systems and employers with the goal of extending care, improving health and reducing costs.
Welldoc has achieved 11 510(k) clearances for diabetes functionality within its digital health platform, and an IP portfolio of 45 patents for its advanced AI and first-in-class tech. With over 80 clinical publications, Welldoc has also built an extensive library of clinical research, including many publications focused on the value of combining CGM with AI-powered digital health solutions. Welldoc is an industry thought leader and has been showcased in prestigious conferences and publications, including South by Southwest, the Wall Street Journal and the Economist. The company has been named the "Best Overall Digital Health Company" by MedTech Breakthrough for the past two years, and is regularly recognized for AI innovation. Most recently, Welldoc was awarded the 2024 Innovation Award from the Business Intelligence Group and the 2024 Healthcare AI Impact award by MDRN Leader.
Cautionary Notes
In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical and medical device markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties. Information about pharmaceutical and medical device products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.
References
1 GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018;392(10159):1789-858.
2 Benjamin EJ, Virani SS, Callaway CW, Chamberlain AM, Chang AR, Cheng S, et al. Heart disease and stroke statistics-2018 update: a report from the American Heart Association. Circulation. 2018;137:e67-e492.
3 Heidenreich PA, Albert NM,
4 Bozkurt B, Ahmad T, Alexander KM, Baker WL, Bosak K, Breathett K, Fonarow GC, Heidenreich P, Ho JE, Hsich E, Ibrahim NE, Jones LM, Khan SS, Khazanie P, Koelling T, Krumholz HM, Khush KK, Lee C, Morris AA, Page RL 2nd, Pandey A, Piano MR, Stehlik J, Stevenson LW, Teerlink JR, Vaduganathan M, Ziaeian B; Writing Committee Members. Heart Failure Epidemiology and Outcomes Statistics: A Report of the Heart Failure Society of America. J Card Fail. 2023 Oct;29(10):1412-1451. doi: 10.1016/j.cardfail.2023.07.006. Epub 2023 Sep 26. PMID: 37797885; PMCID: PMC10864030.
5 DIGITIVA™ Instructions for Use: https://www.astellas.com/en/system/files/1539a14805/digitiva_instructions_for_use.pdf
6 CORE 500™ Digital Stethoscope Instructions for Use: https://cdn.shopify.com/s/files/1/0715/6111/files/LBL-0002512_CORE_500_IFU_Rev_2.0.pdf?v=1718204855
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SOURCE Astellas Pharma Inc.
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