MedTech Dive February 21, 2024
Nick Paul Taylor

The FDA awarded the designation after seeing evidence the digital cognitive behavioral therapy may help reduce liver fat.

Dive Brief:

  • Better Therapeutics has received breakthrough device status for a digital therapeutic designed to treat adults with advanced liver disease, the company said Tuesday.
  • The Food and Drug Administration awarded the designation after seeing the results of a clinical trial that linked the digital cognitive behavioral therapy (CBT) to reductions in liver fat.
  • Better Therapeutics won FDA authorization in Type 2 diabetes in July but, like the wider digital therapeutics sector, has struggled to allay concerns about commercialization. The company has discussed substantial doubts about its ability to continue as a going concern.

Dive Insight:

The breakthrough designation covers...

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Topics: FDA, Govt Agencies, Medical Devices
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