Devices

FDA OKs Siemens’ Somatom X.cite CT Scanner

FDA has cleared a Siemens Healthineers 510(k) for the Somatom X.cite premium single-source computed tomography scanner and its myExam Companion user interface. The device works by guiding users through the exam workflow with precise questions about the patient, for example, a patient’s electrocardiogram waveform for a cardiac study, to “identify optimal acquisition and reconstruction techniques for each patient,” the company says.

Siemens says it analyzed nearly 200,000 scan protocols using artificial intelligence and surveyed clinical experts to identify key questions regarding the framework conditions for an optimized scan result. “On this basis, Siemens Healthineers designed scan strategies and clinical decision trees to aid in proper setup and scanner operation,” it says. “At its core, the myExam Companion renders complicated clinical decision-making into these 20-plus, user-definable clinical decision trees that are displayed at the human-machine interface, either at the operator console or using the scanner’s mobile, detachable tablets.”

The Somatom features an 82cm gantry bore and a patient observation camera, the company says. The 2D visualization camera allows the technologist to closely monitor patients while inside the gantry for potentially fewer patient motion artifacts. It also includes a Visual Patient Instruction, a new visual breath hold indicator on the gantry that guides the patient through the breath hold process with color-guided visual instructions, it says.

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