Pear Therapeutics gets FDA authorization for digital therapeutic for chronic insomnia, through both the precertification and 510(k) pathways

April 03, 2020
by Danielle Bradnan
Truly disruptive

The key thing about this development is that Pear Therapeutics submitted to the FDA for approval via two separate pathways – the precertification pathway, and the more traditional 510(k) pathway. The precertification pathway was expected because digitial therapeutics are the reason that it exists, but by leveraging the 510(k) pathway, Pear is legitimizing the technology not only as part of a special process but as part of the broader approval landscape. Using the 510(k) pathway successfully opens the door for other digital therapeutics and is a turning point in the approval process for digital therapeutics overall. Clients should be engaging with this fast-moving space as it rapidly gains legitimacy in the healthcare ecosystem.

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