FDA clears clinical decision software from Getinge

Getinge announced today that it received FDA 510(k) clearance for its Talis +ACG (advanced clinical guidance) support software.

Talis +ACG includes Talis-Anesthesia, Talis-Perfusion, Talis-RemoteView and Talis-ECMO applications. Getinge says it provides healthcare professionals with an easy-to-use digital companion. The system helps stay compliant with facility care protocols and surfaces alarm/advisory notifications that align with hospital safety practices.

Getinge designed the applications to support hospital-defined clinical and operational process controls. When configured, the controls notify healthcare professionals of deviations form established guidelines or clinical workflow requirements. This helps to reinforce a hospital’s commitment to quality and patient safety, Getinge said in a news release.

Dr. Peter Pronovost of the University Hospitals of Cleveland said Talis provides a “fundamental improvement” in how technology supports healthcare professionals in high acuity environments such as the intensive care unit and operating rooms.”

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