FDA lists Astellas' digital health solution for heart failure management [Yahoo! Finance]
ASTELLAS PHARMA UNSP/ADR (ALPMY)
NASDAQ:AMEX Investor Relations:
astellas.com/jp/en/investors
Company Research
Source: Yahoo! Finance
Classified as a Class I Software as a Medical Device (SaMD), DIGITIVA is not required to undergo the 510(k) premarket submission process. 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. 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, en
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