Devices

Getinge Clinical Decision Support Software Cleared

FDA has cleared a Getinge 510(k) for its innovative clinical decision support software Talis +ACG (Advanced Clinical Guidance), which the company says is intended for use to help promote compliance with care protocols directly at the bedside in high acuity care environments. The clearance covers the company’s Talis-Anesthesia, Talis-Perfusion, Talis-RemoteView, and Talis-ECMO applications, which support hospital-defined clinical and operational process controls. “When configured, these controls actively notify healthcare professionals of deviations from established guidelines or clinical workflow requirements, thereby reinforcing a hospital’s commitment to quality and patient safety,” the company says.

The device is designed to aid in improving compliance with hospital-developed clinical safety practices. “One in four hospitalized patients suffer harm,” Getinge says. “A key strategy to reducing harm is monitoring compliance with a hospital’s safety practices in real time using this new technology from Talis. This is a fundamental improvement in how technology supports healthcare professionals in high acuity environments such as the intensive care unit and operating rooms.”

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