FDA Approves Digital Health Solution for Heart Failure Management
DAIC
SEPTEMBER 19, 2024
tim.hodson Thu, 09/19/2024 - 09:42 Sept. 18, 2024 – Astellas Pharma Inc. recently announced that Digitiva, a non-invasive digital health solution for heart failure management, has been listed with the U.S. Food and Drug Administration (FDA). Digitiva is classified as a Class I Software as a Medical Device (SaMD) and is exempt from 510(k) premarket submission*.
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