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PR inside: XVIVO Announces FDA Receipt of PMA Application for The XVIVO Heart ...

(PR-inside.com) CAUTION-Investigational device in the US. Limited by Federal (United States) law to investigational use. The safety and effectiveness of this device have not been established. The XVIVO heart technology is not commercially available in the US.

GOTHENBURG, SE / ACCESS Newswire / September 28, 2026 / XVIVO Perfusion AB (STO:XVIVO)(LSE:0RKL)(FRA:3XV) - Today, XVIVO announced that the U.S. Food and Drug Administration (FDA) has received the Premarket Approval (PMA) application for the XVIVO Heart Assist Transport System. The application is supported by clinical data from the PRESERVE IDE trial, as well as additional evidence from the PRESERVE Continued Access Protocol (CAP) trial ..

https://reports.pr-inside.com/xvivo-ann ... 227960.htm
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