← References

US FDA Grants Clearance for SleepioRx

Big Health (2024)

Big Health.

URL: https://www.bighealth.com/news/us-fda-grants-clearance-for-sleepiorx

Abstract. Company announcement (8 August 2024) of FDA 510(k) clearance for SleepioRx, a prescription digital therapeutic delivering cognitive behavioural therapy for insomnia over a 90-day programme, indicated for chronic insomnia and insomnia disorder as an adjunct to usual care in adults.