The software has been approved to be used on the company’s Aisys CS Anesthesia Delivery System
Anesthesia Delivery System with Et Control. (Credit: GE Healthcare)
GE Healthcare has secured pre-market approval (PMA) from the US Food and Drug Administration (FDA) for its End-tidal (Et) Control software designed to help in the automation of anesthesia delivery.
The software has been approved to be used on the company’s Aisys CS Anesthesia Delivery System for general anesthesia delivery.
The FDA approval was driven by the findings of the US-based, multi-center, multi-year MASTER-Anesthesia Trial that featured more than 200 patients, aged 18 and older.
The trial assessed the safety and effectiveness of the Et Control software compared to traditional methods of anesthetic gas delivery during general anesthesia.
With the FDA approval in place, GE Healthcare plans to launch the Aisys CS2 Anesthesia Delivery System with Et Control in the US in the coming months.
GE Healthcare had released the end-tidal concentration control technology initially in Europe in 2010. The company claimed that currently, in more than 100 countries, the Et Control software is being used by anesthesia providers to care for patients.
According to GE Healthcare, the Et Control software by semi-automating the delivery of anesthesia enables anesthesia providers to put targets for end-tidal oxygen and anesthetic agent.
After the targets are set, the software is said to quickly achieve and maintain them, irrespective of changes in the hemodynamic and metabolic status of patients.
GE Healthcare claimed that the software enhances the accuracy of anesthesia delivery and simplifies workflows while cutting down drug waste and reducing the cost of care as well as greenhouse gas emissions.
GE Healthcare anesthesia and respiratory care business general manager Eric Ruedinger said: “Anesthesia providers in the U.S. will have access to the most advanced anesthesia tools available to improve patient care.
“As the long-standing global leader in anesthesia delivery, GE Healthcare invested in the development and clinical validation of this Et Control algorithm, and we are committed to creating clinically relevant solutions that will enhance anesthesia practices into the future.”
Last month, GE Healthcare disclosed plans to launch Edison Digital Health, an AI-powered vendor-agnostic hosting and data aggregation platform.