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Evaluation of CardioMem CM 100 XT and PhysioGate App

There are no published clinical studies where the product CardioMem CM 100 XT has been studied and the company has not submitted any preliminary data from ongoing studies. Due to the lack of evidence demonstrating clinical efficacy/patient benefit when using CardioMem CM 100 XT, TLV concludes that no health economic evaluation of the product can be performed in this case according to the Medical Technology Council's request. TLV therefore leaves the Medical Technology Council's request without action and closes the case from further processing.

Publicerad 07 februari 2022

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