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Medical Devices / Submissions and Approvals

FDA Clears Edwards Lifesciences’s Hemodynamic Monitoring Platform OK’d by FDA

Dec. 7, 2018
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Edwards Lifesciences’ latest HemoSphere advanced hemodynamic monitoring platform received 510(k) clearance from the FDA.

The device includes solutions that enable predictive monitoring of moderate- to high-risk surgical patients, such as its Acumen hypotension prediction index software, which uses AI to determine the likelihood of a low blood pressure event.

HemoSphere also includes a minimally-invasive sensor that automatically updates advanced hemodynamic parameters every 20 seconds.

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