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Edwards Lifesciences Earns FDA OK for Noninvasive Hypotension Prediction Software

June 3, 2021

The FDA has granted 510(k) clearance for Edwards Lifesciences’ predictive software for hypotension, the Acumen Hypotension Prediction Index (HPI), enabling its use with a finger-cuff device.

The noninvasive technology uses the Acumen IQ finger cuff and machine learning to warn clinicians when patients are trending toward hypotension, also known as low blood pressure.

The software, which also automatically calculates parameters, including arterial pressure and cardiac output, was previously only cleared for use with an invasive arterial line.

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