Devices

FDA Approves GE ‘Automatic’ Anesthesia Software

FDA has approved a GE Healthcare PMA for its End-tidal (Et) Control software for general anesthesia delivery on its Aisys CS²Anesthesia Delivery System. The company says it is the only manufacturer in the U.S. approved to offer general anesthesia delivery with the automatic software.

The Et Control software “semi-automates” anesthesia delivery, allowing anesthesia providers to set targets for end-tidal oxygen and the anesthetic agent, according to the company. “Once targets are set, the software quickly achieves and maintains those targets, regardless of changes in the patient’s hemodynamic and metabolic status,” it says. The device also reportedly leads to a potential 44% decline in greenhouse gas emissions due to more efficient use of anesthetic agents.

FDA approval was based on data from the company’s U.S.-based MASTER-Anesthesia Trial, which enrolled over 200 patients aged 18 years and older). The trial evaluated the safety and effectiveness of the Et Control software versus conventional anesthetic gas delivery methods during general anesthesia.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome