Worldwide, around 1 in every 8 people struggle with a mental disorder, with often very debilitating consequences – especially in view of the difficulty to treat many of these conditions. Fortunately, mental health, and thereby addressing indications undermining it, have increasingly gotten on the radar of DTx innovators. This has led to very promising developments; compared to other therapeutic areas, many DTx in mental health have gained FDA approval/clearance, spanning many different indications such as, substance use disorders, insomnia, and posttraumatic stress disorder.
Overall, DTx in mental health followed both the De Novo and 510(k) regulatory pathway and all submissions included clinical performance studies. Noteworthy, is that more than half of the approved/cleared DTx followed the De Novo pathway. On average, it took the FDA 254 days from submission to decision, which is above the average of 238 days for all DTx.
Let’s zoom in on the approved/cleared DTx and the indications they target:
Whereas reSET followed the De Novo pathway to FDA approval, reSET-O gained green light from the FDA through the 510(k) pathway, using reSET as its predicate. Both submissions included clinical performance data on the measurement of abstinence/reduced substance use and improved treatment. It took the FDA on average 430 days to provide approval/clearance.
Nightware Kit followed the De Novo pathway to FDA approval and its submission included clinical evidence focused on the measurement of a change in global score on the Pittsburg Sleep Quality Index. The FDA approved the DTx after 163 days.
FDA clearance followed the 510(k) pathway. The submission contained clinical evidence on the measurement of depression symptoms. The device was cleared after 271 days.
Freespira followed the 510(k) pathway. The submission included clinical performance data on the quantitative improvement in PTSD. The treatment was cleared after 213 days.
FDA approval was obtained by following the De Novo pathway, with a submission including clinical evidence on the testing of variables of the Attention-Attention Performance Index. The FDA approved the DTx after 60 days.
The De Novo pathway was followed, and the submission included clinical data on the achievement of positive and negative predictive value of ASD Dx in relation to clinical diagnostic evaluation. The FDA approved the DTx after 211 days.
For a more detailed overview, check out our report (download pdf below) in which we discuss the approval timeline, indications for use, and supporting evidence that enabled the FDA to clear the currently available DTx in the mental health space.
Any questions? Would you like to discuss DTx with us in more detail? Don’t hesitate to reach out to our team!