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GE Healthcare wins FDA premarket approval for software used in anesthesia delivery system

April 4, 2022 By Sean Whooley

GE Healthcare Aisys_CS2_Anesthesia_Delivery_System_with_Et_Control_001
[Image from GE Healthcare]
GE Healthcare (NYSE:GE) announced today that the FDA granted premarket approval for its End-tidal (Et) control software in anesthesia delivery.

Approval covers the use of the Et control software for general anesthesia delivery on GE Healthcare’s Aisys CS2 anesthesia delivery system. The technology was released in Europe in 2010 and today can be used to deliver anesthesia in more than 100 countries.

The Et control software semi-automates anesthesia delivery to allow providers to set targets for end-tidal oxygen and anesthetic agent, according to a news release. Once the targets are set, the software achieves and maintains the targets regardless of changes in a patient’s hemodynamic and metabolic status, improving anesthesia delivery accuracy and simplifying workflows while reducing drug waste, lowering the cost of care and lowering greenhouse gas emissions, GE Healthcare said.

Et control software may allow for a potential 44% decline in greenhouse gas emissions as a result of more efficient use of anesthetic agents, plus increased accuracy, a 50% reduction in manual keystrokes and a potential 27% reduction in operating room costs.

“Anesthesia providers in the U.S. will have access to the most advanced anesthesia tools available to improve patient care,” Eric Ruedinger, GM of GE Healthcare’s Anesthesia and Respiratory Care business, said in the release. “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.”

Filed Under: Auto-injectors, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Regulatory/Compliance, Technology Tagged With: FDA, GE Healthcare

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at swhooley@wtwhmedia.com.

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