The device has been certified in the EU as a class 2a medical device (CE 2274). The same certification class has been obtained for the AI algorithms within the scope of lung auscultation in children. The medical certification of AI algorithms is the first such certification in the world.The next development phase:
We are working on obtaining further medical certifications for:
- AI algorithms for the heart
- AI algorithms for the respiratory system of adults
We have already been positively evaluated by a Notified Body, which constitutes one of the phases of extending the certification with new functionalities. We intend to close the certification process until the end of this year.
Exhibitor Data Sheet