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About us

 

 

 

 

 

 

The goal in front of our eyes

At Sonovum GmbH, we develop medical devices for non-invasive condition monitoring of the brain, especially for acute care. For the ultrasound recordings of a brain pulse curve, the CE mark for a class IIa product according to MDD has been available since summer 2020. With this biosignal, we serve different research fields of classification and monitoring of neurological conditions.

 

Our partner network

 

Integration into clinical workflows

 

We are currently completing a preliminary clinical study to monitor intracranial compliance to rule out the presence of critical intracranial pressure or reduced compliance. The clinical trial to obtain the CE mark for a class IIb product according to MDR will start in Q4 2022. The market launch is planned for the end of 2023.

 

 

Certificates

Sonovum is qualified as a medical device manufacturer through the certification of the quality management system according to ISO 13485 and our medical devices bear the CE mark. The required documents can be downloaded here.

ISO 13485 -Certificate

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CE-Certificate UltraEasy3

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