Home » Directed Systems Gets 510(k) Clearance for Device for Hypotension During Surgery
Directed Systems Gets 510(k) Clearance for Device for Hypotension During Surgery
Cambridge, UK-based Directed Systems has received the FDA’s 510(k) clearance for a new version of its Hypotension Decision Assist (HDA) software, designed to help anesthesiologists manage hypotension during surgeries.
The software provides a visual display of critical cardiovascular situations in the operating room that assists in the management of hypotensive episodes and cumulative hypotension during surgery, the company said.
A previous version of the software gained FDA clearance in November 2019.
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