Getinge Secures FDA Approval for Talis +ACG Clinical Decision Support Software, Advancing High-Acuity Care in US and EU

Thursday, June 13, 2024

Getinge has received U.S. FDA 510(k) clearance for its Talis +ACG (Advanced Clinical Guidance) software, a breakthrough in enhancing bedside care compliance in high-acuity settings.

This global medtech company announced that Talis +ACG, including applications like Talis-Anesthesia™, Talis-Perfusion™, Talis-RemoteView™, and Talis-ECMO™, will aid healthcare professionals by ensuring adherence to care protocols and providing real-time safety notifications aligned with hospital practices.

In Europe, Getinge has confirmed with the notified body TUV SUD that the Talis products are classified as non-device software, known as Electronic Patient Record (EPR) with Process Control Software (PCS).

This classification enables Getinge to market these applications across the EU, improving care quality in member states.

“This classification allows us to enhance care quality across EU member states,” said Gary Colister, President of Talis Clinical at Getinge.

The Talis applications with +ACG/+PCS software support hospital-defined clinical and operational processes. These controls notify healthcare professionals of deviations from guidelines or workflows, reinforcing hospital commitments to quality and patient safety.

Chief Quality & Clinical Transformation Officer at University Hospitals of Cleveland, commented on the clearance:

“Adding the Talis +ACG tool to Talis’ high acuity patient data systems will improve compliance with clinical safety practices. Real-time monitoring of safety practices with Talis technology is essential in reducing harm in intensive care units and operating rooms.”

Chief Operating Officer at Comprehensive Care Services, Inc. (CCS), expressed similar excitement:

“CCS adopted Talis Clinical’s High Acuity Care Management Platform early on. We are implementing Talis in over 200 hospitals in the US and soon in Europe. We are excited to use the Talis +ACG alarms and advisories based on data from the Talis Platform.

The Talis +ACG will revolutionize our quality improvement efforts, enhancing patient safety and outcomes for our patients and hospital partners.”






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