Devices

Methinks AI Stroke Detection Software Cleared

FDA has cleared a Methinks AI 510(k) for its Methinks CTA Stroke, an artificial intelligence–based software tool that detects suspected large vessel occlusions (LVOs) using CT angiography scans. The software demonstrated 98.2% sensitivity and 91.6% specificity, including detection of distal occlusions up to the MCA-M2 segment, according to the company.

The clearance follows the clearance of Methinks NCCT Stroke earlier this year for identifying suspected LVOs and intracranial hemorrhages using non-contrast CT scans. Together, the two AI tools form what Methinks calls a comprehensive stroke triage platform adaptable to a wide range of healthcare settings.

The company says Methinks CTA Stroke is designed to identify both proximal and distal occlusions in the middle cerebral artery and internal carotid artery with high accuracy. The system integrates with existing hospital platforms, including Microsoft Teams, allowing clinicians to share and review imaging in real time without additional software installation.

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