Out of 350,000 health and wellness apps, only 20 have been FDA cleared as Digital Therapeutics.
Here an app, there an app, everywhere a wellness app…
As reported in Nature Magazine, Apple and Google dominate the provision of apps through the ‘Apple App Store’ and the ‘Google Play Store’ respectively, accounting for around 92% of the mobile app distribution business.
The number of health and wellness apps available in the app store has been estimated at 350,000 apps worldwide with as many as 90,000 new health apps added in 2020 alone.
The FDA emergency order allowed a lot of leeway in what could be marketed as a digital therapeutic, but that time has passed. We are now seeing a major divide between the DTx cleared by the agency and the vast array of health apps and games available on these major stores.
Typically there is no doctor support or reimbursement for medical products that are not cleared, a reality that greatly impacts accessibility of care.
We are going to need a way of accelerating this process to have any hope of reaching the billions of people struggling with their mental health.
