fda

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 …

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

Closed a second round of investment

Directed Systems successfully closed a second round of investment. “Our planned second fundraising round closed successfully in July. This will allow us to continue our ongoing development work and to prepare and submit our first product application to the FDA for US regulatory clearance. This first product to market, currently under FDA review, will provide …

Closed a second round of investment Read More »