Devices

FDA Clears Photon Counting Detector in CT Scanning

FDA has cleared a NeuroLogica (a subsidiary of Samsung Electronics) 510(k) for the addition of Photon Counting Detector (PCD) technology to its OmniTom Elite 16-slice computed tomography (CT) scanner. OmniTom Elite with PCD can generate spectral CT images at multiple energy levels, the company says. “Photon counting is a next-generation CT technology that sorts the different energies of X-rays after they have passed through the scan field,” it explains. “A single X-ray source paired with PCD generates multiple sets of CT data acquired at the same time with configurable energy thresholds without any cross talk between images. PCD provides the ability to capture CT data in multiple energy bands leading to potentially more accurate visualization and segmentation of bone, blood clots, plaque, hemorrhage, and intracranial tumors.” Additionally, the company says there is the potential with PCD to lower the dose requirements, and “fundamentally change” the use of injected contrast.

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