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Getinge receives U.S. FDA 510(k) clearance for Talis +ACG Clinical Decision Support software, pioneering quality of high-acuity care in US and EU

Getinge has been granted U.S. FDA 510(k) clearance for its innovative clinical decision support software Talis +ACG (Advanced Clinical Guidance), steering in a new era of improving quality of care through promoting compliance with care protocols directly at the bedside in high acuity care environments. 

Global medtech company Getinge announces the U.S. FDA 510(k) clearance of its Talis +ACG clinical decision support software, including Talis-Anesthesia™, Talis-Perfusion™, Talis-RemoteView™, and Talis-ECMO™ applications. This milestone 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.

Further strengthening its market presence, Getinge has confirmed with E.U. notified body TUV SUD that the 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.  

“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,” says Gary Colister, President Talis Clinical at Getinge. 

The applications with +ACG/+PCS software are designed to support hospital-defined clinical and operational process controls. When configured, these controls actively notify healthcare professionals of deviations from established guidelines or clinical workflow requirements, thereby reinforcing a hospital’s commitment to quality and patient safety. 

Dr. Peter Pronovost, MD, PhD, FCCM Chief Quality & Clinical Transformation Officer, Veale Distinguished Chair in Leadership and Clinical Transformation University Hospitals of Cleveland, praises the clearance: 

“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.” 

Sean Murtha, CCP, Chief Operating Officer at Comprehensive Care Services, Inc. (CCS), echoes this sentiment:  

“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.” 

To find out more about Talis +ACG Clinical Decision Support software, reach out to or your local Getinge sales representative.

Investor Relations:

Lars Mattsson, Head of Investor Relations
Phone: +46 (0)10 335 0043

Media contact:

Caroline Örmgård, Head of Public & Media Relations
Phone: +46 (0)10 335 0041

About Getinge
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs approximately 12,000 people worldwide and the products are sold in more than 135 countries.