U.S. FDA Grants 510(k) Clearance for Spectral’s DIMI

Immediately enables DIMI to be used within U.S. hospitals, clinics and skilled nursing facilities U.S. skilled nursing facilities market represents an estimated US$2 billion market annually TORONTO, Canada – August 31, 2020 – Spectral Medical Inc. (“Spectral” or the...
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Spectral Medical Provides Corporate Update

Early Tigris trial observations in-line with Euphrates post-hoc results Investigator-driven studies show endotoxin levels significantly elevated in most patients with COVID-induced septic shock Q4 2020 EAA multi-country European launch DIMI traditional FDA 510(k)...
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EAA™ and PMX are licensed and available for use in Canada. PMX is not approved for clinical use in the USA, and is currently undergoing the PMA (Premarket approval) process. EAA™ is FDA cleared for use in the USA. The information presented herein is region specific. Please contact Spectral Medical Inc.to obtain appropriate product information for your country.