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Nuvo Group Receives 510(k) FDA Clearance for Remote Monitoring of Uterine Activity
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TEL AVIV, Israel, June 10, 2021 /PRNewswire/ Nuvo Group a private company commercializing INVU by Nuvo™, an FDA-cleared, patent-protected, prescription-initiated remote pregnancy monitoring platform today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to add a new uterine activity module that provides capability for remote monitoring of uterine activity (UA). With this clearance, INVU can provide a reliable, passive alternative to existing methods of UA measurement. INVU uses only external sensors, allowing it to be used without any invasive component or the need for an in-hospital or in-clinic procedure.
/PRNewswire/ Nuvo Group Ltd. a private company commercializing INVU by Nuvo™, an FDA-cleared, prescription-initiated, remote pregnancy monitoring platform,.
Nuvo Group Submits 510(k) to Federal Drug Administration for Remote Monitoring of Maternal Uterine Activity
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TEL AVIV, Israel, Jan. 13, 2021 /PRNewswire/ Nuvo Group a private company commercializing INVU by Nuvo™, an FDA-cleared, prescription-initiated, remote pregnancy monitoring platform today announced that it has filed a 510(k) notice with the U.S. Food and Drug Administration (FDA) to add a new uterine activity module that provides capability for remote monitoring of maternal uterine activity (MUA). INVU has already received FDA clearance for remote monitoring and measurement of fetal and maternal heart rates.