Swedish medical technology company Getinge has secured the US Food and Drug Administration (FDA) 510(k) approval for its new clinical decision support software.
The new tool, dubbed Talis +ACG (Advanced Clinical Guidance), comprises Talis-Anesthesia, Talis-Perfusion, Talis-RemoteView, and Talis-ECMO applications.
It improves the quality of care by promoting compliance with care protocols directly at the bedside in high-acuity care environments.
The software provides healthcare professionals with an easy-to-use digital companion that keeps them compliant with medical facility care protocols, in line with hospital safety practices.
Getinge Talis clinical president Gary Colister said: “This classification, enables us to market the suite of Talis Clinical applications as non-device software in Europe, enhancing the quality of care across EU member states.”
To further strengthen its market presence, Getinge confirmed with the EU-notified body TUV SUD that the Talis products are classified as non-device software in the EU.
The products are classified as Electronic Patient Record (EPR) with Process Control Software, PCS.
The applications with +ACG/+PCS software are intended to support hospital-defined clinical and operational process controls.
Once configured, the tools will actively notify healthcare professionals about deviations from guidelines or clinical workflow requirements, said the Swedish medical technology company.
University Hospitals of Cleveland chief quality and clinical transformation officer Peter Pronovost said: “Adding the Talis +ACG tool to Talis’ high acuity patient data management systems will support improvements in compliance with hospital-developed clinical safety practices.
Comprehensive Care Services (CCS) chief operating officer Sean Murtha said: “CCS was an early adopter of Talis Clinical’s High Acuity Care Management Platform.
“We have been implementing Talis across the 200+ hospitals we service across the US and shortly in Europe. We are extremely excited to implement the Talis +ACG alarms and advisories, based on the data collected through the Talis Platform.
“The Talis+ ACG will revolutionise our quality improvement journey, enhancing patient safety and continuing to improve outcomes for our patients and hospital partners.”
