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Fractyl Health Gets FDA Breakthrough Device Designation for Weight Maintenance Procedure
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Fractyl Health Gets FDA Breakthrough Device Designation for Weight Maintenance Procedure
Jul 30, 2024 11:18 AM

01:52 PM EDT, 07/30/2024 (MT Newswires) -- Fractyl Health ( GUTS ) said Tuesday its Revita system for use in maintaining weight loss after the discontinuation of GLP-1 drugs has received breakthrough device designation from the US Food and Drug Administration.

The company said the designation will expedite review with the FDA upon successful completion of a pivotal study of Revita in patients with obesity after discontinuing GLP-1 based drugs.

Shares of Fractyl Health ( GUTS ) were down 7.1% in recent trading.

Price: 3.80, Change: -0.29, Percent Change: -7.09

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