Israel's Nuvo Group has received clearance from the US Food and Drug Administration (FDA) to add a new uterine activity module to its INVU remote pregnancy monitoring platform that provides capability for remote monitoring of uterine activity (UA), the company announced Thursday.
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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.
INVU's UA module was tested extensively in a clinical study with 80 patients, in which the INVU UA was recorded simultaneously with and compared to the intrauterine pressure catheter (IUPC), the current gold standard of care.
"The Nuvo team is elated to receive supplemental FDA clearance for remote monitoring of uterine activity," said Oren Oz, founder and CEO of Nuvo Group. "The ability to combine this new indication with remote monitoring of fetal and maternal heart rates allows INVU to provide expectant mothers and their healthcare providers with a comprehensive care system that captures deep data from 32 weeks in the pregnancy – marking a key milestone in our journey to reinvent and advance pregnancy care for the 21st century."
