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 / August 30, 2022

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 / July 15, 2021

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

News & Updates / July 15, 2021

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 »