Directed Systems receives FDA 510(k) clearance for Hypotension Decision Assist (HDA)™
Cambridge, UK – November 27, 2019 – Directed Systems Ltd today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of Hypotension Decision Assist (HDA)TM, a clinical decision support Software as a Medical Device (SaMD) that is installed upon a medically-rated touch-screen computer. HDA is indicated to acquire, process and display arterial pressure and other key cardiovascular …
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