April 15, 2019 / 6:54 AM / in 4 days

BRIEF-FDA Doesn't Grant Permit For Infoscan's Med Recorder

April 15 (Reuters) - INFOSCAN SA:

* SAID ON SATURDAY FDA (FOOD&DRUG ADMINISTRATION) DID NOT GRANT PERMIT FOR LAUNCHING MED RECORDER ON THE US MARKET

* FDA JUSTIFIED THE DECISION SAYING THERE IS INSUFFICIENT EVIDENCE FOR REFERENCE OF MED RECORDER WITH THE DEVICE THAT IS ALREADY AUTHORIZED AND PRESENT IN THE US MARKET AND INDICATED IN THE APPLICATION FORM

* THE MANAGEMENT OF THE COMPANY PLANS TO CONTINUE EFFORTS LEADING TO OBTAINING THE CERTIFICATE FOR MED RECORDER

Source text for Eikon:

Further company coverage: (Gdynia Newsroom)

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