Brief: Pixium Vision Announces FDA Granted Breakthrough Device Designation For Prima System

Pixium Vision SA

31/03/2023 06:08

March 31 (Reuters) - Pixium Vision SA  ALPIX.PA :
    * PIXIUM VISION ANNOUNCES FDA BREAKTHROUGH DEVICE
DESIGNATION FOR
PRIMA SYSTEM IN DRY AMD
    * PIXIUM VISION TO RECEIVE INTERACTIVE COMMUNICATION WITH
FDA
THROUGH PREMARKET REVIEW PHASE OF PRIMA SYSTEM AND POTENTIAL
PRIORITIZED REGULATORY REVIEW
    * BREAKTHROUGH DEVICE DESIGNATION AIMS TO EXPEDITE
DEVELOPMENT OF
MEDICAL DEVICES THAT CAN TREAT OR DIAGNOSE LIFE-THREATENING OR
DEBILITATING CONDITIONS
    * PRIMAVERA EUROPEAN PIVOTAL TRIAL IN DRY AMD FULLY
RECRUITED AND
ON TRACK TO REPORT PRIMARY ENDPOINTS AROUND END OF 2023
    * STREAMLINED REIMBURSEMENT OPTIONS AVAILABLE UPON APPROVAL
IN
UNITED-STATES

Further company coverage:  ALPIX.PA 

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