Devices

Philips Wins Clearance for AI-powered Spectral CT System

FDA has cleared a Philips 510(k) for its new Spectral CT Verida system, marking the U.S. debut of what the company describes as the first AI-powered detector-based spectral CT scanner. The device integrates always-on spectral imaging with artificial intelligence – driven image reconstruction, aiming to improve diagnostic accuracy and workflow efficiency across radiology, cardiology and oncology, it says.

Philips says the system combines a dual-layer detector platform with a deep learning reconstruction engine designed to reduce image noise and enhance clarity. Clinicians can adjust denoising settings based on preference, while the platform simultaneously captures high- and low-energy data in a single scan, enabling both conventional and spectral imaging outputs without additional acquisitions.

The scanner is intended for diagnostic imaging across a range of applications, including head, whole-body, cardiac and vascular imaging, and is cleared for use in patients of all ages, according to the company.

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