Posted by Michael Wonder on 26 Sep 2022
Better Therapeutics submits de novo request to US FDA for BT-001 investigational prescription digital therapy for type 2 diabetes
22 September 2022 - Submission follows completion of first in class trial demonstrating significant improvements in A1c reduction with investigational therapy targeting the root causes of type 2 diabetes.
Better Therapeutics today announced that it has submitted a de novo classification request to the US FDA seeking marketing authorisation for BT-001, its potentially first in class digital therapeutic designed to use cognitive behavioural therapy to treat type 2 diabetes in patients 18 years and older.
