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TrivarX Secures FDA Backing for Major Depression AI Screening Trial

7:03pm on Monday 2nd of June, 2025 AEST Healthcare
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TrivarX Secures FDA Backing for Major Depression AI Screening Trial

7:03pm on Monday 2nd of June, 2025 AEST
Key Points
  • FDA endorses TrivarX's adaptive pivotal trial design for MEB-001
  • Trial to recruit at least 563 patients across multiple US sleep clinics
  • MEB-001 algorithm previously showed 87% sensitivity and 72% specificity
  • Engagement with prominent hospitals progressing to secure high-volume sites
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