Devices

Siemens New MR Whole-Body Scanner Cleared

FDA has cleared a Siemens Healthineers 510(k) for the MAGNETOM Cima.X 3 Tesla (3T) magnetic resonance imaging whole-body scanner. The device offers the “strongest-ever gradient system for a clinically released whole-body MR scanner, making smaller structures in the body visible,” according to the company. It also has features that are designed to enhance scientific research and overcome key imaging challenges in visualizing cancer and other diseases, it says. For example, the device’s Physiologging feature provides precise, time-stamped physiological data from the patient, including heart and respiratory rates, while performing functional brain imaging.

“The new Open Recon platform enables clinicians to run custom algorithms for image reconstructions directly on the scanner, which functions as the computing platform,” the company says. “The result is immediate reconstruction of MR images. Traditionally, clinicians have needed to use a separate reconstruction platform for research purposes. Open Recon also enables seamless data-sharing between MR scanners and institutions to facilitate research.”

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