Medtech company Getinge has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its Talis + Advanced Clinical Guidance (ACG) clinical decision support software.
The software suite, which includes Talis-Anesthesia, Talis-Perfusion, Talis-RemoteView, and Talis-ECMO applications, is designed to enhance the quality of high-acuity care in the US and EU.
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The FDA clearance represents a major step forward in providing digital tools for healthcare professionals to assist in adhering to medical facility care protocols while complying with hospital safety practices through alarm and advisory notifications.
Getinge has also confirmed with TUV SUD, an EU-notified body, that the Talis products are classified as non-device software in the EU.
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.”
The Talis +ACG/+PCS software applications are specifically engineered to support hospital-defined clinical and operational process controls.
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By GlobalDataOnce properly configured, these controls can actively notify any deviations from established guidelines or clinical workflow requirements for healthcare professionals.
This approach helps hospitals maintain quality and patient safety.
Known as electronic patient records (EPR) with process control software (PCS) in the EU, these applications are set to revolutionise the way high-acuity care is delivered across Europe.
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.”
In April 2024, Getinge obtained a European Union Medical Device Regulation certificate for its Advanta V12 covered stent system.
