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TrivarX Secures FDA Backing for Major Depression AI Screening Trial
11:16am on Tuesday 28th of January, 2025 AEDT
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Healthcare
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TrivarX Secures FDA Backing for Major Depression AI Screening Trial
11:16am on Tuesday 28th of January, 2025 AEDT
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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