FDA-Cleared AI Therapy Delivery at Scale
#1Woebot received FDA Breakthrough Device designation for adjunctive MDD treatment; Limbic Access received UKCA marking as a Class IIa medical device for mental health triage and is deployed across NHS primary care at scale; Spring Health's AI-driven precision mental health platform has raised $450M+ and serves millions of employer-sponsored members, routing many to digital CBT programs that replace initial human therapy. RCT evidence from SilverCloud, Beating the Blues, and Woebot studies published in JMIR and The Lancet Digital Health demonstrates non-inferiority to human-delivered CBT for mild-to-moderate anxiety and depression, the conditions that constitute the majority of outpatient psychiatric caseloads.