FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

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

Dec. 7, 2018

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.

View today's stories