Senzime files new FDA application for TetraGraph
Press release: Uppsala, March 28, 2019. Senzime AB (publ) today announces the filing of the new 510(k) application to the US Food and Drug Administration (FDA) for the TetraGraph system. This filing is in line with previous communication and strategy to decrease the overall time to reach FDA clearance and subsequent introduction on the US market. The FDA application is part of Senzime's strategic launch plan for the TetraGraph system, with primary focus of launching in Europe, Japan, Korea and the United States – central markets for monitoring patients undergoing surgery with