Brief: Intellego Technologies Updates On HAI Solutions' FDA Application

Intellego Technologies AB

27/03/2023 08:45

March 27 (Reuters) - Intellego Technologies AB
 INTE.ST :
    * UPDATES ON HAI SOLUTIONS
    * END PRODUCT THAT HAI SELLS IS MEDICAL DEVICE, IS SUBJECT
TO
APPROVAL FROM FDA
    * HAI WILL SHORTLY SUBMIT ITS FDA APPLICATION AND HAS IN
DIALOGUE
WITH FDA BEEN INFORMED THAT FDA APPROVAL FOR APPLICATION SHOULD
COME AT END OF 2023
    * AS PRODUCT HAS LOW RISK CLASSIFICATION, THERE ARE NO
SIGNIFICANT
OBSTACLES TO FDA AUTHORISATION

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