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U.S. FDA Grants Breakthrough Device Designation to Laguna Diagnostics’ mRNA Gene Biomarker Test to Aid in Differentiation of Schizophrenia and Bipolar I Disorder

IRVINE, Calif., April 28, 2026 /PRNewswire/ — Laguna Diagnostics, LLC today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the company’s mRNA Gene Biomarker Test, a novel blood-based test designed to aid in the differentiation of schizophrenia and bipolar I disorder in symptomatic patients.

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TytoCare Secures FDA De Novo for First AI-Powered Eardrum Analysis

NEW YORK, April 27, 2026 /PRNewswire/ — TytoCare, a virtual care company enabling accessible, high-quality primary care from home, today announced it has received FDA De Novo classification for the first model of Tyto Insights™ for ENT Suite, marking the creation of a new regulatory category for AI-powered ENT image analysis.

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