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.