MedTech Dive February 21, 2024
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...
Today's Sponsors
Today's Sponsor