fda

Directed systems Ltd anounces a brand-new version of, and fDA 510(k) clearance for, its operating room solution hypotension decision assist (HDA)® designed to help better manage hypotension during surgery

News & Updates /

Directed Systems selects Advantech as the hardware platform to introduce a new enhanced HDA-OR2 model – a medical grade networked tablet with remote capabilities that will enable access to case review summaries, remote software upgrades and web-based performance metrics HDA will be showcased in the United States for first time at the 75th Anniversary of …

Directed systems Ltd anounces a brand-new version of, and fDA 510(k) clearance for, its operating room solution hypotension decision assist (HDA)® designed to help better manage hypotension during surgery Read More »

Directed Systems receives FDA 510(k) clearance for Hypotension Decision Assist (HDA)™

News & Updates /

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 …

Directed Systems receives FDA 510(k) clearance for Hypotension Decision Assist (HDA)™ Read More »