Getinge Receives FDA 510(k) Clearance for Talis +ACG Clinical Decision Support Software

Getinge has received U.S. FDA 510(k) clearance for its Talis +ACG (Advanced Clinical Guidance) support software, which includes Talis-Anesthesia, Talis-Perfusion, Talis-RemoteView, and Talis-ECMO applications. 
 
Getinge has also confirmed with EU-notified body TUV SUD that Talis products are classified as non-device software in the EU, where they are referred to as Electronic Patient Record (EPR) with Process Control Software (PCS).
 
The FDA clearance marks a significant leap forward in supporting healthcare professionals with an easy-to-use digital companion that helps them stay compliant with medical facility care protocols, as well as surfaces alarm/advisory notifications that align with hospital safety practices.
 
Dr. Peter Pronovost, MD, PhD, FCCM Chief Quality & Clinical Transformation Officer, Veale Distinguished Chair in Leadership and Clinical Transformation University Hospitals of Cleveland, commented: “Adding the Talis +ACG tool to Talis’ high acuity patient data management systems will support improvements in compliance with hospital developed clinical safety practices. One in four hospitalized patients suffer harm. A key strategy to reducing harm is monitoring compliance with a hospital’s safety practices in real time using this new technology from Talis. This is a fundamental improvement in how technology supports healthcare professionals in high acuity environments such as the intensive care unit and operating rooms.”
 
The applications with +ACG/+PCS software are designed to support hospital-defined clinical and operational process controls. These controls will actively notify healthcare professionals of deviations from established guidelines or clinical workflow requirements, reinforcing a hospital’s commitment to quality and patient safety.
 
Sean Murtha, CCP, Chief Operating Officer at Comprehensive Care Services, Inc. (CCS), added: “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 revolutionize our quality improvement journey, enhancing patient safety and continuing to improve outcomes for our patients and hospital partners.”