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:  

Substance use disorders:

• reSET: Provision of cognitive behavioral therapy to patients, aged 18 years and older, with substance use disorder (SUD), to increase abstinence from a patient’s abuse of substances during treatment, and to increase retention in the outpatient treatment program
• reSET-O: Increase retention of patients, aged 18 years and older, with opioid use disorder (OUD) in outpatient treatment through cognitive behavioral therapy

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.  

Nightmare disorders:

• Nightware Kit: Provision of vibrotactile feedback on an Apple Watch based on an analysis of heart rate and motion during sleep for the temporary reduction of sleep disturbance related to nightmares in adults aged 22 years or older who suffer from nightmare disorder or have nightmares from posttraumatic stress disorder (PTSD)

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.

Insomnia:

• Somryst: Improving insomnia symptoms in patients, aged 22 years and older, with chronic insomnia by providing neurobehavioral intervention

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.

Panic disorder and posttraumatic stress disorder:

• Freespira: Relaxation treatment for reduction of stress through breathing exercises for patients with panic disorder (PD) and/or posttraumatic stress disorder (PTSD)

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.  

ADHD:

• EndeavorRx: Improving attention function in children, aged 8-12 years old, with primarily inattentive or combined-type ADHD, who have a demonstrated attention issue

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.

Autism spectrum disorder:

• Cognoa ASD Diagnosis Aid: Aiding healthcare providers in diagnosing autism spectrum disorder (ASD) in patients, aged 18-72 months old, who are at risk of development delay

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!  

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