Astellas Announces Desert Oasis Healthcare as First Health System to Implement DIGITIVA™ for Heart Failure Management
Astellas Pharma US has partnered with Desert Oasis Healthcare (DOHC) to pilot DIGITIVA™, a non-invasive digital health solution for heart failure management. DIGITIVA combines the CORE 500™ Digital Stethoscope with a smartphone app featuring AI-driven coaching and educational resources. The system provides clinicians with patient reports highlighting cardioacoustic biomarkers and physiological parameters to enable earlier intervention. The partnership will evaluate DIGITIVA's effectiveness through clinical measures, cost metrics, and patient quality of life assessments using the Kansas City Cardiomyopathy Questionnaire. DIGITIVA received FDA listing in September 2024.
Astellas Pharma US ha collaborato con Desert Oasis Healthcare (DOHC) per testare DIGITIVA™, una soluzione digitale non invasiva per la gestione dell'insufficienza cardiaca. DIGITIVA unisce il CORE 500™ Digital Stethoscope con un'app per smartphone che offre coaching basato sull'IA e risorse educative. Il sistema fornisce ai medici rapporti sui pazienti che evidenziano biomarcatori cardioacustici e parametri fisiologici per consentire interventi più precoci. La collaborazione valuterà l'efficacia di DIGITIVA attraverso misure cliniche, metriche di costo e valutazioni della qualità della vita dei pazienti utilizzando il Kansas City Cardiomyopathy Questionnaire. DIGITIVA ha ricevuto l'approvazione della FDA nel settembre 2024.
Astellas Pharma US se ha asociado con Desert Oasis Healthcare (DOHC) para pilotar DIGITIVA™, una solución digital no invasiva para la gestión de la insuficiencia cardiaca. DIGITIVA combina el CORE 500™ Digital Stethoscope con una aplicación para smartphone que cuenta con coachings impulsados por IA y recursos educativos. El sistema proporciona a los clínicos informes de pacientes que destacan biomarcadores cardioacústicos y parámetros fisiológicos para permitir una intervención más temprana. La asociación evaluará la efectividad de DIGITIVA a través de medidas clínicas, métricas de costo y evaluaciones de la calidad de vida del paciente utilizando el Kansas City Cardiomyopathy Questionnaire. DIGITIVA recibió la aprobación de la FDA en septiembre de 2024.
아스텔라스 제약 미국이 데저트 오아시스 헬스케어(DOHC)와 협력하여 심부전 관리를 위한 비침습적 디지털 건강 솔루션인 DIGITIVA™를 파일럿 운영합니다. DIGITIVA는 CORE 500™ 디지털 청진기와 AI 기반 코칭 및 교육 자료를 제공하는 스마트폰 앱을 결합합니다. 이 시스템은 임상 의사에게 심장음 바이오마커 및 생리적 매개변수를 강조한 환자 보고서를 제공하여 조기 개입을 가능하게 합니다. 이 협력은 Kansas City Cardiomyopathy Questionnaire를 사용하여 임상 측정, 비용 지표 및 환자 삶의 질 평가를 통해 DIGITIVA의 효과성을 평가할 것입니다. DIGITIVA는 2024년 9월 FDA 승인을 받았습니다.
Astellas Pharma US s'est associé à Desert Oasis Healthcare (DOHC) pour piloter DIGITIVA™, une solution numérique non invasive pour la gestion de l'insuffisance cardiaque. DIGITIVA combine le CORE 500™ Digital Stethoscope avec une application pour smartphone offrant un coaching basé sur l'IA et des ressources éducatives. Le système fournit aux cliniciens des rapports de patients mettant en avant des biomarqueurs cardioacoustiques et des paramètres physiologiques pour permettre une intervention précoce. Le partenariat évaluera l'efficacité de DIGITIVA à travers des mesures cliniques, des métriques de coût et des évaluations de la qualité de vie des patients en utilisant le Kansas City Cardiomyopathy Questionnaire. DIGITIVA a reçu son approbation par la FDA en septembre 2024.
Astellas Pharma US hat sich mit Desert Oasis Healthcare (DOHC) zusammengetan, um DIGITIVA™, eine nicht-invasive digitale Lösung zur Behandlung von Herzinsuffizienz, zu testen. DIGITIVA kombiniert das CORE 500™ Digital Stethoscope mit einer Smartphone-App, die KI-gestützte Schulungs- und Bildungsressourcen bietet. Das System liefert Kliniken Patientenberichte, die kardiophysikalische Biomarker und physiologische Parameter hervorheben, um eine frühzeitige Intervention zu ermöglichen. Die Partnerschaft wird die Effektivität von DIGITIVA anhand klinischer Messungen, Kostenmetriken und Bewertungen der Lebensqualität der Patienten unter Verwendung des Kansas City Cardiomyopathy Questionnaire bewerten. DIGITIVA erhielt im September 2024 die FDA-Zulassung.
- First implementation of DIGITIVA™ system in a major healthcare network
- FDA listing achieved in September 2024
- Partnership includes effectiveness evaluation based on clinical and cost metrics
- None.
DIGITIVA was designed with the goal of improving heart failure management by providing patients with the CORE 500™ Digital Stethoscope developed by Eko Health Inc. and an easy-to-use smartphone app built on the Welldoc, Inc. platform, with AI-driven personalized digital coaching, as well as educational resources from the American Heart Association. Clinicians also receive tailored patient reports assessed by a clinical review team, highlighting relevant cardioacoustic biomarkers, such as S3 sounds and EMAT (electromechanical activation time), as well as physiological parameters with the goal of enabling earlier intervention when needed.
The partnership will also gather data to evaluate the effectiveness of DIGITIVA based on key clinical measures and cost of care metrics relevant to patients, healthcare providers and the overall health care system. In addition, patients will complete the Kansas City Cardiomyopathy Questionnaire (KCCQ), which assesses their perception of heart failure symptoms, quality of life and how it impacts their physical and social function periodically throughout the partnership.
Brian Hodgkins, Pharm.D., Executive Vice President of Clinical Operations and the Heritage Provider Network ACO, Desert Oasis Healthcare
"DIGITIVA exemplifies Desert Oasis Healthcare's commitment to exploring innovative health technologies with the potential to better the lives of both patients and providers. Placing patients at the center of their care, DIGITIVA provides enhanced heart health data tracking, automated feedback and educational resources from home, while equipping clinicians with patient-specific data potentially signaling when earlier intervention could be beneficial. Desert Oasis Healthcare is proud to be the first health system in the country to provide patients and cardiology providers with access to DIGITIVA and look forward to better understanding its potential impact."
Patrick Keenan, DIGITIVA Program Lead, Rx+ Business Accelerator, Astellas
"Implementing DIGITIVA in a real-world setting represents a significant achievement as the first SaMD and medical device offering from Astellas in
DIGITIVA was listed with the FDA in September 2024. For additional information, please see the DIGITIVA™ Instructions for Use here1 and the CORE 500™ Digital Stethoscope Instructions for Use here2.
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 Desert Oasis Healthcare
Formed in 1981 as one of the first medical groups in the desert communities of southern
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 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 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 DIGITIVA™ Instructions for Use: https://www.astellas.com/en/system/files/1539a14805/digitiva_instructions_for_use.pdf
2 CORE 500™ Digital Stethoscope Instructions for Use: https://ekohealth.com/ifu
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SOURCE Astellas Pharma Inc.
FAQ
What is DIGITIVA™ and how does it help heart failure patients?
When did Astellas (ALPMY) receive FDA listing for DIGITIVA™?
Which healthcare system is the first to implement Astellas' DIGITIVA™?
What components are included in the DIGITIVA™ system?
