Fractyl Health announced that the U.S. Food and Drug Administration, FDA, has granted Breakthrough Device Designation, BDD, for the Company’s Revita System for use in the maintenance of weight loss after discontinuation of GLP-1 drugs. Breakthrough Device Designation will enable priority regulatory review with the FDA upon successful completion of the REMAIN-1 study, as well as the potential for an early or accelerated decision on reimbursement by the Centers for Medicare & Medicaid Services. REMAIN-1 pivotal study underway to accelerate pathway for weight maintenance indication for Revita(R), with anticipated data readouts beginning in Q4 2024
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