A new technology for video games has been cleared by the FDA as a therapeutic treatment.
What’s happening:
- Digital therapeutics startup DeepWell DTx has received a new clearance from the United States Food and Drug Association for their video game technology which reduces stress levels and blood pressure
The big idea:
- DeepWell DTx has developed a biofeedback software development kit that is available for video game developers and studios to be able to directly embed into their video game
- The software built by DeepWell DTx provides biostimulation through interactive media to activate the vagus nerve in users and also reduces sympathetic nervous system activation
Why it matters:
- The new clearance from the United States Food and Drug Association for DeepWell DTx’s biofeedback software technology is not just for one specific video game, but is something that can be broadly applied to mobile app developers and video game publishers globally which unlocks the potential for digital therapeutics to become significantly more accessible to users
Going deeper:
- DeepWell DTx also is planning to begin pursuing clinical validation of their technology for other indications, including sleep disorders, immune disorders and even Alzheimer’s
By the numbers:
- Only approximately 20 companies have been officially cleared as digital therapeutic by the United States Food and Drug Association for a mobile app or game
- DeepWell DTx is the 1st ever approval in the United States for a digital therapeutics software development kit
The fine print:
- While video game based digital therapeutics have been making strides with clinical validation, there have been very few big winners as of yet with Chamath Palihapitiya backed Akili Therapeutics previously being acquired at an all time low valuation after going public in a SPAC transaction and subsequently seeing its share price decline by more than -95% as a publicly traded company
