Big Health
received FDA clearance for SleepioRx in August 2024 and for DaylightRx in September 2024, the first FDA-cleared non-drug treatment for generalized anxiety disorder, and raised $23.7 million in February 2026 to scale commercial expansion following new CMS reimbursement codes for digital mental health treatments.
- Country
- United States
FDA cleared
CMS reimbursement code
us
Coverage
| CN | EU | US | |
|---|---|---|---|
| regenerative-personalized | ✓ | ✓ | ✓ |
Regulatorsfdaemanmpa
Technologies
| Name | Cluster | Risk | |
|---|---|---|---|
| Digital therapeutics | regenerative-personalized | Medium | → |
Compiled by BIOECON via the bioecon-brief pipeline.
Compliance
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