Brief: Ambu Announces FDA Clearance Of First-Generation Single-Use Colonoscope

Ambu A/S

20/09/2023 09:46

Sept 20 (Reuters) - Ambu A/S  AMBUb.CO :
    * ANNOUNCES FDA CLEARANCE OF FIRST-GENERATION SINGLE-USE
COLONOSCOPE
    * ANNOUNCES 510(K) REGULATORY CLEARANCE FROM THE U.S. FOOD
AND
DRUG ADMINISTRATION (FDA) OF ITS SINGLE-USE  COLONOSCOPE
SOLUTION, THE AMBU® ASCOPE™ COLON AND THE ENDOSCOPY SYSTEM, THE
AMBU® ABOX™ 2
    * WITH THE FDA CLEARANCE, AMBU WILL APPLY AN INITIAL MARKET
TEST
APPROACH IN A FEW DEDICATED U.S. CENTERS TO EVALUATE CLINICAL
PERFORMANCE, IN CLOSE COLLABORATION WITH PHYSICIANS

Source text for Eikon:  ID: 
Further company coverage:  AMBUb.CO 

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