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FDA authorise Better Therapeutics’ digital therapeutic device

July 11, 2023

Better Therapeutics has received marketing authorisation from the US Food and Drug Administration (FDA) for its prescription-only digital behavioural therapeutic device, AspyreRx.

AspyreRx (previously BT-001) is intended for delivering cognitive behavioural therapy to type 2 diabetes (T2D) patients aged 18 years and above.

The authorisation has been granted for the device based on the efficacy and safety data of a randomised controlled study, which assessed 668 participants.

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