Senzime updates and optimizes strategy for FDA approval
Press release: Uppsala, February 15, 2019. Senzime AB (publ) today announces the intent to re-submit the existing 510(k) application to the US Food and Drug Administration (FDA). Based on an updated version of the TetraGraph, the existing 510(k) application will be re-submitted and Senzime thereby seeks to decrease the overall time to FDA approval.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 general