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Imaginostics’ QUTE‑CE MRI platform has demonstrated the ability to provide quantitative data on vascular health with unprecedented clarity—up to 10x better than conventional gadolinium-enhanced MRI—using a safe iron-based contrast agent. The technology has received FDA Breakthrough Device Designation for use in patients with advanced kidney disease where traditional contrast agents are contraindicated. Early studies have shown promise in detecting Alzheimer’s-related vascular changes decades before symptom onset and supporting drug development targeting vascular biomarkers. Supported by NIH grants and the Alzheimer’s Drug Discovery Foundation, the company is advancing toward pivotal clinical trials.
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