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AlgoDx receives FDA clearance for sepsis detection software

AlgoDx, a leading medical AI company with EU and UK-approved ML-based software for sepsis prediction in commercial use, has announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its sepsis detection software using a proprietary algorithm, NAVOY CDS. This milestone marks a major step forward in AlgoDx’s expansion into the U.S. market.

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