Devices

GE Healthcare Gets AIR Recon Imaging Clearance

FDA has cleared a GE Healthcare 510(k) for its AIR Recon DL for 3D and Propeller imaging sequences for use during magnetic resonance imaging (MRI) clinical procedures, claimed to enable better image quality and shorter scan times. The device's image reconstruction technology for MRI is now expanded from 2D to 3D imaging sequences to help physicians quickly and confidently diagnose patients with “improved signal-to-noise ratio and sharpness,” the company says. “3D imaging provides for more clinical efficiency, allowing radiologists to eliminate the need for multiple 2D acquisitions — potentially leading to faster diagnosis.”

Additionally, GE Healthcare says AIR Recon DL is now compatible with Propeller, a “motion-insensitive imaging sequence particularly important for anatomies susceptible to motion such as respiration during MRI exams, as well as pediatric, neurodegenerative, geriatric, and claustrophobic patients who have difficulty remaining physically still for the duration of an MRI scan.”

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