Category: BioUtah News

bioMérieux receives U.S. FDA Special 510(k) clearance and CLIA-waiver for its BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel Mini

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Marcy-l’Étoile (France), June 26th, 2024 – bioMérieux, a world leader in the field of in vitro diagnostics, today announces that its BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel Mini has received U.S. Food and Drug Administration (FDA) Special 510(k) clearance and CLIA-waiver (Clinical Laboratory Improvement Amendments). The COVID-19 pandemic demonstrated the need for healthcare professionals to […]

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Foldax® Reports Positive Clinical Results for TRIA Mitral Surgical Heart Valve Using Novel LifePolymer Material

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SALT LAKE CITY – June 11, 2024 – Foldax®, Inc., a leader in the development of innovative, polymer heart valves, today announced positive 30-day results from a prospective, multicenter, single-arm, clinical study of the TRIA™ mitral surgical heart valve with LifePolymer™ conducted in India. At 30 days following surgery, TRIA demonstrated favorable safety and hemodynamics, […]

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Canary Speech Secures $13 Million in Series A Funding

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Led by Cortes Capital, LLC, Sorenson Communications, LLC., SMK (Japan), and Hackensack Meridian Health, Series A funding expands the AI-driven capabilities of the groundbreaking vocal biomarker health tech company PROVO, Utah, June 12, 2024 /PRNewswire/ — Canary Speech, Inc. (Canary), the leading AI-powered voice biomarker health tech company, has secured a $13 million Series A […]

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