Better Therapeutics (Nasdaq:BTTX) announced that the FDA authorized its AspyreRx prescription digital therapeutic for diabetes.
AspyreRx, formerly BT-001, provides cognitive behavioral therapy to patients 18 years or older with type 2 diabetes. The prescription-only digital therapeutic (PDT) underwent review through the FDA de novo pathway. The company submitted an FDA de novo request in September 2022 for the therapeutic. Earlier this year, it suggested that authorization would come at some point in 2023.
San Francisco-based Better Therapeutics says the authorization creates a new class of diabetes digital behavioral therapeutic devices. The company expects to launch AspyreRx in the fourth quarter of this year.
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